QA Senior Manager

at  Amgen

PREFERRED QUALIFICATIONS:

• Medical Device, Biotech, or pharmaceutical industry experience
• Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and with high quality results
• Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution
• Ability to operate in a matrixed or team environment with site, functional, and executive leadership – including strong facilitation and influential skills
• Experience overseeing quality of suppliers or external parties
• Knowledge of device regulatory requirements and device validation activities
• Significant Quality experience in manufacturing facilities
• Able to successfully manage workload and timelines
• Ability to negotiate a strategic position after taking feedback from multiple sources
• Strong project management, problem-solving, and analytical skills
• Auditor Certification or experience performing audits

RESPONSIBILITIES INCLUDE:

• Onboard new suppliers and manufacturing facilities to support uninterrupted supply to Amgen. Identify supplier development initiatives through onboarding/diligence/day to day interactions and create a plan to implement and measure success.
• Mature relationships with existing suppliers to improve quality outcomes, performance, and compliance. Ensure mitigation plans and quality improvement plans are put into place, risk-based, and remain on track for suppliers not meeting Amgen’s performance standards.
• Provide Quality oversight and direction to device suppliers and applicable subsuppliers – including assessment of supplier change notifications, maintenance of quality agreements, supplier audits, quality record management, day to day supplier interactions, and periodic monitoring requirements. Ensure decisions are risk-based with the patient at the forefront of decisions.
• Engage with site leaders and partners in manufacturing, process development, supply chain, and quality to advance operations and build a resilient supply network.
• Review and approve supplier related deviations and investigations and ensure robust actions are implemented to prevent reoccurrence. Participate in complaint investigations and drive actions with suppliers to improve the patient experience.
• Ensure consistent approach in manufacturing sites and across suppliers by sharing of best practices across quality team and key stakeholders. Participate and lead continuous improvement projects related to risk based oversight, quality oversight, and defect management.
• Represent ESQ in regulatory inspections and site audits as required.