QA Sr. Manager - External Quality
at Amgen
Dún Laoghaire, County Dublin, Ireland -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 25 Nov, 2024 | Not Specified | 29 Aug, 2024 | 10 year(s) or above | Analytical Skills,Leadership | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
PREFERRED SKILLS & EXPERIENCE
- 10 + years’ biotech or pharmaceutical industry experience
- Significant Quality experience at Synthetics 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
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
- 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
REQUIREMENT SUMMARY
Min:10.0Max:15.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Clinical Pharmacy
Graduate
Proficient
1
Dún Laoghaire, County Dublin, Ireland