Are you a highly autonomous and driven Quality professional ready to make an immediate impact in a dynamic external manufacturing environment? Do you possess a strong quality mindset and a broad understanding of pharmaceutical quality and regulatory requirements?
As an integral member of our cross-functional contract manufacturing team, you will provide critical Quality and Compliance oversight for contract labs, CMOs, or raw material SREs, ensuring alignment with Clinical Trial Applications (CTA) and Marketing Authorisations. You will be empowered to hit the ground running, leveraging your expertise to drive quality excellence and ensure the seamless supply of our innovative medicines.
Key Responsibilities:
- Serve as a key Quality representative within our cross-functional contract manufacturing team, collaborating closely with Business Operations, Analytical Science, Process Development, Supply Chain, and more.
- Lead the negotiation and approval of Quality Agreements.
- Take the lead in preparing contract manufacturing sites for and represent our company during product-specific Regulatory Inspections and Notified Body audits.
- Confidently present on relevant topics during inspections, demonstrating a strong understanding of the subject matter.
- Review and approve Master Batch Records.
- Act as a Quality approver for deviations, change controls, and CAPAs.
- Develop and maintain inspection playbooks.
- Proactively identify and mitigate quality risks at CMOs and testing laboratories, escalating issues to management as needed.
- Perform Person in Plant activities as required.
- Provide data for Annual Product Reviews (APRs).
- Manage audit commitments through to completion.
- Execute tactical batch disposition activities to support timely lot release.
Authority:
- Make decisions regarding the release or rejection of batches (with dynamic considerations for SREs).
- Approve or reject deviations, Change Controls, and CAPAs.
- Approve Quality Agreements (QAGR).
- Provide the Quality position on GMP-related topics and site strategy.
- Approve Master Batch Records and Raw Material Specifications.
Basic Qualifications:
- Doctorate degree & 2 years of directly related experience OR
- Master's degree & 4 years of directly related experience OR
- Bachelor's degree & 6 years of directly related experience OR
- Associate's degree & 10 years of directly related experience OR
- High school diploma / GED & 12 years of directly related experience
Preferred Qualifications:
- 10+ years of experience within the biotech or pharmaceutical industry.
- Proficiency in additional European languages (desirable, not essential).
- Significant Quality experience in aseptic manufacturing facilities.
- Proven ability to facilitate and influence senior stakeholders and partners.
- Demonstrated ability to effectively manage workload and timelines.
- Familiarity with basic project management tools.
- Ability to negotiate strategic positions while considering diverse feedback.
- Strong project management, problem-solving, and analytical skills.
- Demonstrated experience leading cross-functional teams, consistently delivering on-time, high-quality results.
- Excellent collaboration and communication skills, with the ability to balance diverse inputs and drive issue resolution.
- Ability to operate effectively in a matrixed or team environment, interacting with site, functional, and executive leadership.
- Experience driving decision-making using DAI principles.
- Experience with the "variation management" process.
