Interim QA Manager

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.

Dela