Excellent opportunity for a candidate with strong experience dealing with CMO's to move into a Senior QA Manager role
Senior Manager External Quality- Pharmaceuticals-Dublin
Excellent opportunity for a candidate with strong experience dealing with CMO's to move into a Senior QA Manager role with a world leading Biopharmaceutical Company.
This role will have two key requirements Quality and Compliance oversight at the CMO/ Lab site and Alignment with CTA /Marketing Application.
- Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain etc.
- Serve as the main Quality point of contact for deviations, change controls, CAPAs author and revision of quality agreements and batch disposition etc. related to the product.
- Manage CMOs to contractual obligations relative to Quality Agreement, specifications, quality, safety and regulatory requirements.
- Review completed production batch records as necessary and approve master batch records, and other cGMP documents from CMOs / Contract Laboratories.
- Provide quality oversight of the manufacturing, testing, and release of products at CMOs.
- When necessary, facilitate communication regarding deviations, change controls, complaints and batch disposition between the CMO and staff members.
- Meet with Quality, Production, Regulatory, and Logistics personnel at the CMO sites as necessary or during regularly scheduled meetings for issues relating to products.
- Represent Quality and quality activities from the CMO site on project teams.
- Provide Quality support of CMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement
- Ensure that the CMO Site has an appropriate Data Integrity program and if needed conduct DI assessment at that site.
- Representation at product-specific Regulatory Inspections and/or during Notified Body audits of CMO Site, as presenter as applicable or required.
- Manage inspection readiness of the CMO & prepare Inspection playbooks to ensure success
- Represent the company as Person-In-Plant as applicable or required
- Identify and mitigate Risk at the CMO or testing Laboratories.
- Monitor and communicate site performances in means of quality metrics to company and Contract Manufacturer
- Escalate risks or roadblocks to management
- Identify prioritization opportunities and determine when escalation is necessary
- Strong partnership/relationship with CMO / testing Lab
- 10 + years biotech or pharmaceutical industry experience
- Additional European Languages - desirable not essential
- Significant Quality experience at Aseptic Manufacturing facilities
- Able to facilitate and influence senior stakeholders and partners
- Able to successfully manage workload and timelines
- Familiarity with basic project management tools
- Ability to negotiate a strategic position after taking feedback from multiple sources
- Strong project management, problem-solving, and analytical skills
- Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
- Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
- Ability to operate in a matrixed or team environment with site, functional, and executive leadership
- Experience driving decision making by using DAI principles
- Experience with the "variation management" process
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.