Connecting to LinkedIn...

Vacancy Details

Quality

Senior QA Manager - Cork

Contract Type: Contract
Sector:
Location: Cork
Date: 20/10/2016
Job Reference: 85435

Job Description

Senior QA Manager

Our client, a medical device company in Cork are currently looking to recruit a Senior QA Manager for their site.

Description
  • Quality and Compliance lead ensuring quality standards are achieved and maintained at third-party manufacturers (for API, GMP-intermediates and GMP Starting Materials) and commodity API, Excipient and Bio-material (= raw materials for Large molecule manufacturing) suppliers. This is accomplished through management, and oversight on Quality Operations functions for external business partners. This oversight includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, L&A, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS).
  • Functions and activities include Quality assurance review and approval functions (such as batch production documentation, analytical records, Change Control, Validation), Compliance audit activities, creation and management of supplier development plans. Ensures business, quality and compliance goals adhere to government-issued environmental, health, safety, quality and regulatory policies and guidelines. Represents the JNJ credo and quality values in contact with the third-party manufacturers and will comply with the JNJ regulations for ethic and business conduct in order to strengthen the reputation
  • Evaluation, development and management of quality systems at the third-party manufacturers (API, GMP intermediates and GMP starting materials) and commodity API, excipient and Bio-material manufacturers by conducting audits, by performance monitoring and implementing development programs and by installing quality agreements
  • Coordinate Quality Project summaries and Project review
  • Responsible and accountable for the quality of products produced by third-party manufacturers (API, GMP intermediates and GMP starting materials) and commodity API, excipient and Bio-materials manufacturers (including change management, deviation and complaints handling, validation)
  • Handles issues, by personal intervention and /or appropriate delegation within the organization to drive to resolution. Fields actions, recalls, compliance audit observations etc. may be among the escalated topics that require his/her involvement.
  • Effectuates and permanently maintains inspection readiness at the third-party manufacturers (API, GMP intermediates and GMP starting materials) and commodity API, Excipient and Bio-materials manufacturers. Supporting of third-party manufacturers and API suppliers during regulatory inspections and audits and during the development of corrective action plans.
  • 8 years of experience in a pharmaceutical and/or biotechnology environment with proven experience in QA, API manufacturing, process engineering, QC or R&D.

Competencies/Skills Required:
  • In-depth knowledge of cGMP and other applicable regulations of the different regulatory authorities (for API as well as Excipient and Bio-Materials)
  • Working knowledge of analytical chemistry, microbiological test methods, chemical processes as well as Bio-material manufacturing processes. Able to apply this knowledge in combination with quality system requirements to evaluate and (if applicable) to lead the development of quality systems at the different third-party manufacturers
  • Clear, specific and concise verbal and written communication skills.
  • Ability to build up interdependent partnerships with excellent interpersonal interaction skills particularly the ability to interface with multiple non-business partners and in some instances influence without direct authority. Strong people leadership and development track record. Ability to work effectively across many different cultures and geographical regions.
  • Demonstrates strong knowledge of Quality Management competencies such as auditing, quality engineering, root cause analysis, FMEA, design control, project management , specification and stability management
  • Ability to assess and manage risks in a prudent manner, sound decision making and problem solving expertise. He/she must be able to understand the circumstances to determine which critical support functions must be consulted prior to final decision and disposition. As most of the decisions are not standard, he/she must rely upon their experience, business knowledge and key technical collaboration.
  • Ability to balance multiple tasks, objectives and priorities.
  • Cost sensitive in managing own expenses and finding the `right balance? between Q&C needs and effective implementation costs for the quality development of the third-party manufacturer.
  • Ability to travel 50% of time
  • He/she consistently interfaces with external business partners for the purpose of driving the development of core process reliability at external sites.
  • Frequently collaborates with internal operating companies and R&D partners on a wide variety of product, process, project and compliance related issues. Interfaces with internal functional groups to broker the necessary technical support for external partners. Interactions are required with Tech Ops, Procurement, EHS, Planning, the different manufacturing sites, but also with the other quality groups as Compliance, Quality unit API manufacturing, Quality Unit F/F manufacturing. Quality systems and the different qualified persons

For further information on this Senior QA Manager role in Cork please contact Jenny Dore on 0212066287 / jenny@hero.ie
Check out all our open jobs on our HERO Recruitment website ? www.hero.ie

Please Note: HERO Recruitment will not forward your details to any company without your prior approval



Clients we are proud to work with

W1siziisijiwmtyvmduvmdgvmtivmtkvmdevndq5l2fiynkucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmtkvntuvnze4l2fszxjllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavmtevmtewl2fsa2vybwvzlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavndavmje4l2jvc3rvbi5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjavntivotayl2nhbwj1cy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmdcvmze0l2nlbgvzdgljys5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmtkvnjcxl2noywvsbguucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjevmzqvote3l2nvy2fjb2xhlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjevndgvnzm1l2nyzwdhbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmdmvoti1l2dvb2rtyw4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmtgvodewl2phbmrqlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivmzivmtcwl0pmtc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjivndcvnde3l2xpbgx5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivntkvnjeyl21hcmluzs5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmtcvntqzl21lzhryb25pyy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmzavote4l21lcml0lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjmvndqvodexl211c2dyyxzllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmdavmja5l3blbm4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjqvmtivnjg5l3bpdm90lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmjyvmzuxl3byb3h5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmzgvmtm0l3j1c2fslnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvntmvoty1l3nhbm1pbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvmdyvnza4l3n0zxjpcgfrlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjuvmjmvmjgwl3n0cnlrzxiucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvndqvota2l3rozxjtb2xpbmcucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmtivmdyvmtivntgvmjcvnze0l3ntdc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
More

“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
More

“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
More

Clients we are proud to work with

W1siziisijiwmtyvmduvmdgvmtivmtkvmdevndq5l2fiynkucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmtkvntuvnze4l2fszxjllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavmtevmtewl2fsa2vybwvzlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjavndavmje4l2jvc3rvbi5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjavntivotayl2nhbwj1cy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmdcvmze0l2nlbgvzdgljys5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjevmtkvnjcxl2noywvsbguucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjevmzqvote3l2nvy2fjb2xhlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjevndgvnzm1l2nyzwdhbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmdmvoti1l2dvb2rtyw4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjivmtgvodewl2phbmrqlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivmzivmtcwl0pmtc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjivndcvnde3l2xpbgx5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjivntkvnjeyl21hcmluzs5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmtcvntqzl21lzhryb25pyy5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
W1siziisijiwmtyvmduvmdgvmtivmjmvmzavote4l21lcml0lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjmvndqvodexl211c2dyyxzllnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmdavmja5l3blbm4ucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjqvmtivnjg5l3bpdm90lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmjyvmzuxl3byb3h5lnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvmzgvmtm0l3j1c2fslnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjqvntmvoty1l3nhbm1pbmeucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvmdyvnza4l3n0zxjpcgfrlnbuzyjdlfsiccisinrodw1iiiwimjuwede1mfx1mdazzsjdxq
W1siziisijiwmtyvmduvmdgvmtivmjuvmjmvmjgwl3n0cnlrzxiucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmduvmdgvmtivmjuvndqvota2l3rozxjtb2xpbmcucg5nil0swyjwiiwidgh1bwiilciyntb4mtuwxhuwmdnlil1d
W1siziisijiwmtyvmtivmdyvmtivntgvmjcvnze0l3ntdc5wbmcixsxbinailcj0ahvtyiisiji1mhgxntbcdtawm2uixv0
More