- To lead and supervise a team, ensure that each team member is trained and qualified for their tasks
- Build and foster a team environment where employees know what is expected of them, can work well together and can flourish and further develop themselves. Share the workload in the team, ensuring that all feel noticed, heard and have a reasonable challenging workload. Ensure that due dates and KPI's are met.
- Review all clinical and Pharmacovigilance QMS documents and ensure they comply with the relevant guidelines.
- Collaborate with and seek alignment with other departments ( clinical, medical, PHV.) to ensure compliancy with GXP guidelines
- Ensure continuous inspection readiness (GCP and GVP) internally and for the clinical trials
- Identify risks, identify and communicate areas for improvement, provide subject matter expert reports as required. Identify documents which need to be created or updated and ensure this is organized.
- Resolve problems and conducts investigations associated with deviations, complaints, non-conformances, Change Controls, CAPA, Risk Assessments, protocols and reports in collaboration with other Pharming departments
- Act as trainer, coach and expert for Quality Assurance Officers and other departments, and ensure that everyone has suitable GCP/GVP training.
- Perform internal and external audits to determine compliance with GCP, GLP and GVP, communicates the results to relevant stakeholders and ensure that corrective and preventative actions are taken to close CQA observations.
- Perform e-TMF audits
- Participate in company projects as CQA subject matter expert
- Assess effects of changes to regulations and guidelines covering clinical trial activities and ensure timely implementation of these changes.
- Represent CQA as a single point of contact and provides CQA guidance
- MSc Biotechnology, chemistry, biopharmaceutics or equivalent field, or BSc Biotechnology, chemistry, biopharmaceutics or equivalent field
- Min. 8 years of experience in (bio)pharmaceutical environment
- Min. 6 year of experience in Quality Assurance
- Preferably 1-year managerial experience
- A highly competitive salary
- holiday allowance (for NL)
- A minimum of 30 vacation days
- An excellent pension plan
- Commuting allowance
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Manager Clinical QA - Leiden, Nederland - Pharming Group
Beschrijving
About Pharming
Pharming Group (Nasdaq: PHAR/Euronext Amsterdam: PHARM) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules, biologics, and gene therapies that are in early to late-stage development. Pharming is headquartered in Leiden, Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia Pacific.
Our Culture
Pharming is committed to our core values: "We Care, We Collaborate, We Walk the Talk", which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged. Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.
Purpose of the role
The Manager of Clinical QA leads and supervises the Clinical QA team, being accountable for GCP and GVP oversight, inspection readiness, and ensuring the compliance of studies with Pharming SOPs and all applicable worldwide regulations and guidelines (, FDA, EU, ICH, and national regulations).
Areas of responsibility
Knowledge:
Experience:
What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:
You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all "Pharmers".
Also important We truly value a healthy life-work balance with a lot of flexibility.
