Key Responsibilities:

• Ensure establishment, maintenance and effectiveness of quality and data management systems and practices. Oversee all aspects of product lifecycle.
• Lead and manage a global QA organization and/or global quality project team and contribute to and regularly monitor the strategic milestones of the product lifecycle strategy.
• Ensure adherence to global and local safety and regulatory internal and health authority standards.
• Ensure adequate oversight of proactive quality risk management process including quality risk assessments and submission/inspection readiness activities.
• Support inspection preparation and facilitation and participate in audits and inspection follow-up activities including CAPA preparation.
• End-to-End Product Quality Strategy - Accountable for the overall product quality strategy, ensuring business continuity and managing product risks. This includes overseeing new lines, site transfers, validations, and analytical transfers.
• Quality Oversight - Provide expert quality guidance, technical support and quality leadership. Act as global quality lead in product related Quality escalations, recalls and BPDR handling. Support global site readiness for product pre-approval inspections across the LM platform / network. Maintain global quality oversight on Product Launch, Supply Chain, and Technology Transfers. Be involved in major product relevant investigations, particularly multi-sites deviations and significant recurring deviations, by leading or supporting site task forces in their investigations.
• Regulatory Compliance -Maintain oversight of product life cycle, including regulatory filings, product registrations, variation management, product introductions, launches, and technology transfers. Support inspection preparations.
• Cross-Site Change Control - Secure appropriate management of change controls across different sites to maintain consistent product quality, continuous quality improvement and product compliance. The responsibility of cross site changes is with Lead Site.

Essential Requirements:

• Undergraduate degree in Pharmacy, Chemistry, Biology or related subject; higher level degree preferred. Additional knowledge in Quality Assurance / Compliance
• 10+ years’ experience in GMP-regulated industries including QA/QC in Biotech area.
• Working knowledge of FDA/EMA/ICH regulatory requirements
• Broad cGMP experience with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
• Ability to synthesize detailed information and clearly communicate across quality, manufacturing and supply chain.

The pay range for this position at commencement of employment is expected to be between $176,400 and $327,600 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.