Manager, External Supply QA Cmo Quality Operations
vor 12 Stunden
Reporting to the Associate Director, External Supply Quality Assurance, you will be responsible for managing and supporting global drug substance and drug product production efforts at Contract Manufacturing Organizations (CMOs). The Manager will work with CMO’s and cross-functional internal teams to transfer new processes, manage changes, resolve issues, deviations, and perform regular review of performance KPI’s. The Manager may also lead process improvement or life cycle projects and may perform on-site support at CMO’s if needed.
This role is Global in nature and this individual will need to collaborate across the Global Quality Leadership Team as well as with CMO partners to assure that our Quality Assurance programs are implemented consistently across the network.
**Responsibilities**:
- Responsible to partner with CMO to ensure strong business partnership with Quality team working to ensure Quality system alignment with CSL Behring and the External Supplier (CMO). Leads Quality related sub-projects in the corresponding relationship.
- Quality lead to support successful tech transfer of drug substance and drug product from one CMO to another
- Assure commercial readiness after tech transfer
- Escalate risks to key stakeholders and relevant functions.
- Represent QA in cross-functional project teams such as External Supply Integration, tech transfer, and process improvements.
- Continuously evolve the Global CMO Quality Program in alignment with standards provided by the External Supply Integration department.
- Design and implement a Global Quality Program for CMOs.
- Develop and maintain all CMO Quality program processes, quality agreements, qualification audits, policies, and SOPs wherever necessary.
- Maintain knowledge of new/updated regulations and industry trends.
- Manage the activities of supplier quality agreements, which includes writing, editing, reviewing, updating, and routing the agreements for approvals between CSL Manufacturing Site, and suppliers.
- Participation and representation of Quality at joint meetings e.g. Operations, Business Review Meetings.
- Lead Quality-related topics at off-site visits and teleconferences for discussion and review of external supplier performance and cGMP compliance.
- Provide personal in-plant assistance as necessary for contract manufacturing relationships.
- Review/approve controlled cGMP documents including SOPs, material specifications, investigation protocols/reports, process validation protocols/reports, as applicable.
- Act as the responsible person for CSL Behring to ensure all appropriate regulatory guidelines in the following areas are followed:
- Coordinating and promptly performing any recall operations for medicinal products together with the CSL responsible groups.
- Ensuring that relevant customer complaints are dealt with effectively together with the CSL responsible groups.
- Approving any subcontracted activities which may impact on GDP.
- Deciding on the final disposition of returned, rejected, recalled or falsified products.
- Approving any returns to saleable stock.
- Acting as the SME for External Supply Quality Assurance organization in the dedicated cross-functional teams.
**Requirements**:
- A four-year degree in a relevant business or science, or equivalent education and experience.
- Minimum of 5 years’ experience in a GxP environment in the pharmaceutical industry.
- Thorough understanding of required regulations including but not limited to FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.
- Strong industry and quality systems knowledge (internal and external) experiences within the industry.
- Must be comfortable working in a global, matrix organization.
- Experience in CMO business highly preferred.
- Strong organizational skills.
- Managing diversity, time management and planning.
- Strong written and verbal communication skills.
- Directing others and delegation.
- Fluent in English (written and spoken).
- This role requires local and some (overseas) travel, 20% travel.
LI-DNI
**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Behring**:
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