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Contact Info
Brian Christensen
Life Science

+353 (0)1 685 47 47
brian.c@lifescience.ie
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Details

QA Director


Reference:BC/HQ00001934 Location: Dublin North
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: €100000+
May be suitable for: QA Director, QA Manager, Qualified Person


Our client is a virtual developer of generic formulations for global markets. They are seeking a highly-skilled QA Director to join their North-Dublin based-organisation.

Role

This position requires a leadership role working with key stakeholders, including of management of external & internal providers and with client organizations, to promote processes and performance in support of a culture of quality, customer interactions for QA and prevention of quality issues.

Plays a crucial role in the business by ensuring that products meet the standards and all external and internal requirements set by the industry and our customers.
Assures consistent quality of production (internal and external) by developing and enforcing good manufacturing practice (GMP) systems, validating contract manufacturers (CMO) and processes, providing documentation and managing his staff.
This position is responsible for management and oversight of staff for delivery and adherence to Quality Agreements, or similar (where applicable), Project Specific Quality Assurance & Audit Plans, QA interactions with clients, and oversight of CAPA for escalated quality issues. This individual represents QA Leads and manages staff in support of management of client and/or contractor audits including CAPA oversight and coordination with internal stakeholders in management support across regulatory inspections

Responsibilities

1. Management and oversight to QA staff, ensuring quality of QA
2. QA interactions with Clients and Contractors in support of quality plans, issue escalation and notification, corrective and preventive actions to client-specific issues and quality governance
3. Representation and direction to staff in support of client and contractor audit management; including preparation, audit hosting and CAPA response to client audit reports/outcomes as applicable
4. Coordination of QA support to client & contractor -specific regulatory inspection management (e.g.; inspection of investigator sites) and management of staff in support of activities as applicable
5. Collaborate with internal teams and functions and other internal stakeholders (e.g; Legal) with respect to QA Engagement operations, client/ contractor interactions and quality issues
6. Management of development, maintenance and adherence to execution of Quality Agreements (where applicable) and study-specific Quality Plans (where required) with Clients and Contractors
7. Contribute to evolving standards and requirements for QA Lead Engagement processes, including operational execution and continuous process improvement
8. Represent QA Lead Engagement in developing quality assurance approaches/strategies with Clients and external operations
9. Serve as QA lead representation to operational and/or quality governance as appropriate
10. Serve as key point of QA contact in client and/or contractor capability
11. Talent management, colleague performance management, development and engagement
12. External auditing of the component suppliers and contractors when required (with the QP)
13. Liaise with the RA (regulatory affairs department) in relation to Marketing Authorisation and variations
14. Preparation of Quality Quarterly reports
15. Ensure that all activities are in compliance with the requirements of Good Manufacturing Practice

Requirements

• Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance / QP) or equivalent experience a plu• 10 years’ experience in a regulated environment (MUST include significant experience in GMP) in roles of a related discipline (e.g. Quality Assurance, Operations, Project Management),
• 10 years’ experience in pharmaceutical/CMO/CRO industries
• Proven ability to manage complex quality issues and deliver against quality strategies in a global clinical setting
• Proven ability to understand, analyze and communicate the impact of GMP quality issues affecting the drug development process and the future supplies
• Working knowledge of GMP processes and Pharmacovigilance standards and quality and compliance processes (e.g. audit, compliance, CAPA)

Contact Brian Christensen on 01 6854747 or submit your CV to brian.c@lifescience.ie for immediate consideration
If you would like further Information you can contact the recruiter directly:

Brian Christensen | Tel: +353 (0) 1 685 4747