Our client, a medical device company in Cork are currently looking to recruit a Senior QA Manager for their site.
- 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.
- 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 / email@example.com
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