Sr. Mgr External Quality

Career Category

Job Description

• Responsibilities

• Be an integral quality member of Amgen 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 Amgen product.

• Manage CMOs to contractual obligations relative to Quality Agreement Amgen 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 Amgen products at CMOs.

• When necessary facilitate communication regarding deviations change controls complaints and batch disposition between the CMO and Amgen 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 Amgen products.

• Represent Quality and quality activities from the CMO site on Amgen project teams.

• Provide Amgen 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 Amgen 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 Amgen 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 Amgen 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

• Preferred Skills & Experience

• 10 years biotech or pharmaceutical industry experience

  Additional European Languages - desirable not essential

• Significant Quality experience at Aseptic Manufacturing facilities

• QP eligibility desirable

• 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