Interim QA Manager
South of Sweden | KonfidentielltInterim Search has been appointed to recruit an interim QA Manager to a global Medtech Company in the south of Sweden.
Responsabilities and main tasks:
- Contribute to the QA strategy and overall planning.
- Work with department managers and process owners to develop QA strategies that meet or exceed department and corporate quality goals.
- Provide leadership and expertise within Quality Assurance throughout the company.
- Monitor regulations and guidelines that have an impact on the business.
- Maintain professional and technical knowledge within the QA team by reviewing professional publications; establishing personal networks; participating in professional societies.
- Contribute to training and continuous learning of quality mindfulness including amongst other things good documentation practices, issue escalation, and process improvement for all employees.
- Act as GDP Responsible Person, including responsibilities as defined in EU Guidelines on Good Distribution Practice (2013/C 343/01).
- Vendor assessment/qualification.
- Contribute to the management of the internal & external audit strategy.
- Plan, coordinate and execute internal/external audits.
- Monitor, assess, and manage/investigate reported issues.
- Prepare for and coordinate inspections by external parties.
- Assess potential external GDP/GMP service providers.
- Review service agreements/Technical Quality Agreements for external GDP/GMP work.
- Monitor GDP/GMP services performed by external parties.
- Gather and present quality metrics for key stakeholders including periodic management reviews.
- Continuously assess and update QMS.
- Identify potential areas of improvement within the company.
- Drive company-wide, departmental, and/or focused process improvement projects.
- Support the business with its operational process improvement efforts.
Whom we are looking for:
- Master’s degree or PhD with focus in Pharmaceuticals, Life Sciences, or another similar technical field
- Solid experience from the Pharmaceutical/ Biotech industry
- 5+ years of demonstrated experience within QA
- Strong knowledge of and experience in international GDP/GMP regulations and guidelines, industry practices, and experience in implementing QMS in a regulated environment
- Prior experience as RP would be a strong asset
- Experience with audit and compliance in the pharmaceutical industry
- Experience with EU and FDA inspections, inspection readiness and follow-up would be an asset
- Experience with gap analysis and risk management
- Experience with oversight of outsourced activities
The process:
The assignment is expected to start as soon as possible and will go on for 6 months full-time.
Are you available and have the right background? Apply today!
Responsible recruitment consultant is Lena Arrelöv and Hedda Tornert.
