Senior Manager, Global Supplier Quality Management (GSQM) - Seattle, WA or Toulouse, FR
Senior Manager, Global Supplier Quality Management (GSQM) - Seattle, WA or Toulouse, FR
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Job Description
The Senior Manager Global Supplier Quality Management (GSQM) will serve as the global process owner for Just-Evotec Biologics (JEB) overseeing GMP supplier performance and ensuring compliance with JEB policies as well as FDA EMA and other international regulations. This role is responsible for fostering effective internal and external partnerships including suppliers contract organizations and strategic partners.
We would consider someone from either greater Seattle WA area or Toulouse France.
Responsibilities
Lead the global supplier quality team managing the GMP supplier lifecycle: selection onboarding requalification and risk management.
Schedule and oversee supplier audits ensuring timely completion and compliance.
Manage contracts and consultant auditors supporting GMP audits and international inspection readiness.
Oversee internal GMP Supplier Quality events (e.g. complaints deviations CAPAs) with escalation of critical issues affecting patient safety product quality or supply.
Act as project manager for assigned quality initiatives including Change Control Review Board GMP QMR and Quality Risk Management.
Assess and ensure external supplier readiness for health authority inspections and client audits - represent QA in internal and external meetings.
Perform and approve impact and risk assessments.
Serve as Business Process Owner (BPO) and Subject Matter Expert (SME) for supplier quality including system and tool deployment.
Develop maintain and deliver controlled documents and training materials for the Supplier Quality Management program.
Support audits and inspections including preparation of responses and corrective actions.
Communicate deliverable status to clients management and stakeholders.
Monitor and report global Supplier Quality Management metrics; support site-level compliance.
Conduct periodic reviews of the Supplier Quality program and drive continuous improvement.
Oversee investigations of supplier-related quality issues and root causes.
Travel to JEB sites as required.
Qualifications
Bachelors degree with 8 years in Quality and 10 years in the biotech industry.
Expertise in Supplier Quality Management processes and methodologies.
Strong knowledge of biologics and pharmaceutical regulations risk management and science-based decision-making.
Project management experience.
Ability to collaborate cross-functionally and promote a quality-focused culture.
Proficiency in Microsoft Office and electronic quality management systems (e.g. Veeva QualityDocs eQMS).
The base pay range for this position at commencement of employment is expected to be $112560 to $154100; Base salary offered may vary depending on the individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision short-term and long-term disability company paid basic life insurance 401k company match flexible work generous paid time off and paid holiday wellness and transportation benefits.
Evotec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race gender age disability genetic information gender expression gender identity national origin religion sexual orientation or veteran status.
Required Experience:
Exec
Employment Type
Full-Time
