Germany Job Openings
Summit Therapeutics Sub, Inc.
Associate Director, Quality - EU
FULL TIME
October 9, 2024
Location: Spain, Germany, Netherlands, Ireland, Belgium or Poland
Overview of Role:
The Associate Director, Quality-EU will support batch certification of IMP and commercial products for EU and Rest of the World. Responsible for QA oversight of manufacture and testing activities conducted at CMOs in Europe.
Role and Responsibilities:
- Perform QA aspects to maintain routine supply of IMP and commercial products to EU and Ro W
- Perform EU QP certification as necessary
- Oversee routine QA activities and ensure drug manufacture and testing activities at CMOs are compliant with applicable c GMPs, EU regulations and product registration details.
- Ensure Data integrity standards are maintained
- Partner closely with Supply Chain and Technical Operations and provide advice on GMP issues.
- Ensure EU GMP inspection readiness activities for CMOs
- Responsible for qualification and monitoring of CMOs and GMP service providers
- Review controlled documents, including manufacturing and packaging batch records, validation protocols and technical reports
- Conduct internal audits of departments and processes
- Provide guidance on issues concerning QP certification
- Review existing policies and procedures, and recommend new and enhanced policies that ensure compliance to regulations
- Work closely with CMOs regarding Quality matters
- Ensure issues are identified and managed through to resolution in a timely manner and deliverables are met.
- Participate in developing, reporting, reviewing and trending of quality and performance metrics
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Bachelor’s degree (or international equivalent) in chemistry, biochemistry, biotechnology, or other related life sciences discipline. Higher level degree preferred.
- Minimum of 8+ years’ experience in GMP Quality in pharmaceutical industry
- Eligible to act as Qualified Person (QP) as per article 49 of Directive 2001/83/EC
- Experience hosting HA inspections and auditing CMOs
- Strong understanding, knowledge of current EU Regulations and upcoming changes
- Ability to multi-task and prioritize workload
- Excellent written and verbal communication skills
- Attention to detail, self-motivated with a strong sense of work ethic
- Excellent interpersonal skills and collaborative
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