QA Manager

Do you have experience from working with QA and GDP/GPM? Are you ready for the next step in your career? We might have the job you are looking for! We are searching for a QA Manager for our customer in the MedTech industry in Lund!
This is a consultant assignment for 6 months where you will get the opportunity to develop and to contribute with your knowledge.

Responsibilities
QA Strategy
• 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.

QA Expertise
• 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.

Compliance & Quality Oversight
• 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 of the company 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.

Process Improvement
• 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.



Your profile
In order to succeed in this position, we believe that you should possess:
• 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

• Service minded and self-motivated team player with a “can do attitude”.
• Excellent communicator, solid social skills and an ability to collaborate with and present to individuals of varying levels of authority, including senior and Executive Leadership.
• Excellent writing and verbal skills, including English.
• Ability to independently solve problems and work with multi-disciplinary project teams.
• Able to operate in an academic centric SME with strong growth ambitions.
• Able to work in a matrix, fluid and high paced environment.




About the organisation
This is a consultant assignment at our customer for 6 months. During this time you will be hired by us at QRIOS.

QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you. Being a consultant at QRIOS gives you opportunities to try different industries, companies and roles.