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Vacancy Details

Quality

Associate Director of Engineering Compliance - Cork

Contract Type: Permanent
Sector:
Location: Cork
Date: 1/07/2019
Job Reference: 104599
Contact Name: Orla Crowley - Healy
Contact Email: talent@hero.ie

Job Description

Associate Director of Engineering Compliance

Our client, a pharmaceutical company in Cork are currently looking to recruit an Associate Director of Engineering Compliance for their site.

Purpose of Role:
The Associate Director of Engineering Compliance is responsible for maintaining all aspects of compliance within the site Engineering team, including GMP, EHS, Technical and Engineering compliance. The leadership style is one of collaboration, coaching and facilitating the team to a high performing organization. This will require a substantial amount of time with the various Engineering areas such as Utilities, Capital Projects, Facilities, Engineering Centre of Excellence. The Associate Director of Engineering Compliance moulds the culture to one that supports a High Performance Organisation.

Characteristics Required
  • Personal accountability and responsibility, continuous self-development through colleague collaboration in an open and trusting environment where all colleagues are comfortable to voice their opinions
  • S/He will continuously stretch themselves and the department teams’ performance and inspire all colleagues to accomplish extraordinary results.
  • The Associate Director of Operational Compliance will continuously benchmark with best in class industry to challenge corporate and site thinking on best practice compliance performance.


Job Purpose:
  • Interprets internal and external regulatory and compliance developments and communicates action to Department and site as appropriate.
  • Ensure that departmental procedures are aligned with corporate standards and policies. This scope will cover EHS, GMP and Engineering standards.
  • Gembas areas frequently ensuring that areas are audit ready at all times. Through collaborative and open dialogue coach area owners in the compliance requirements. Assist them in formulating corrective plans where required and putting a process in place confirming that actions are addressed.
  • Critical to the role is promoting the use of ‘Leader Standard Work’. Through the Eng. leadership team ensure that area owners are performing the duties set out in Leader Standard work and highlight any deficiencies.
  • Act as coach for all members of department in compliance. Works closely with teams to ensure that day to day activities are compliant and aligned with procedures.
  • Works closely with team members on investigations to ensure that through thorough and robust investigation, true root causes are identified and robust CAPAs are generated and executed.
  • To embed a culture of compliance and safety excellence within the Engineering team, and to work with compliance peers across the business to ensure best practice compliance is implemented.
  • Accountable for development and deployment of visual metrics within the Department
  • Conduct field audits to verify that procedures, processes are completed to site requirements.
  • Develops innovative lean compliance systems that anticipate future department needs aligned with industry best practice
  • Engages with senior stakeholders (internal & external) to influence outcomes as appropriate.
  • Core team member at site Quality and EHS Councils.
  • Accountable for PIR (Permanent Inspection Readiness) within the department, including development and maintenance of a proactive compliance risk register for the Department to ensure consistent PIR.
  • Accountable for all maintenance & adherence to standards owned within the department e.g. QMS, Engineering Standards and EHS standards.
  • Responsible for proactive monitoring of CAPAs to ensure holistic trends are proactively resolved
  • Responsible for overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA
  • Ensures compliance is at the core in development of departmental strategies.
  • Departmental Tier 4 owner for Compliance
  • Participate and comply with our manufacturing division Quality Management System (QMS) requirements, including ownership, as relevant.
  • Responsible for driving a culture of Continuous Improvement by deploying our organization Six Sigma tools within the IPT. Model our organization Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.
  • Owner for the departmental compliance calendar ensuring that all compliance activities for the department are tracked, highlighted and action plans are in place for.
  • Direct Management responsibility for Compliance Team. Accountable for delivering on compliance projects.

The Ideal Candidate:
  • >10 years’ experience in pharmaceutical industry.
  • >5 years’ experience in operational leadership.
  • Demonstrated technical knowledge and experience in compliance (GMP, Eng., Technical.
  • Degree in (Science/Engineering). Masters would be an advantage.
  • Green Belt.
  • Demonstrated use of Leadership Behaviors
  • Evidence of Continuous Professional Development
  • Demonstrated self-motivation/direction skills with a continuous improvement focus.
  • Demonstrated technical capability in EHS.
  • Demonstrated ability to lead and realise improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma teams, CI teams etc.
  • Advanced PC skills such as Excel, Word, PowerPoint.

For further information on this Associate Director Role role in Cork please contact Orla Crowley Healy on 086 80449473/ talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Clients we are proud to work with

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“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

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“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
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“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

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“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
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Clients we are proud to work with

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