Senior Manager Quality Assurance
Job ID: R-103930
Location: West Greenwich, RI, US 02817
The Senior Manager Quality Assurance (QA) position will lead a multi-layered team in the Amgen Rhode Island Quality Control (QC) organization responsible for QC Equipment Management, QC Investigations, Supplier Quality Management, QC Analytical and Quality Systems.
The Senior Manager QA will report directly to the Director of Quality Control and as part of this leadership team and will contribute to further developing the culture of Safety, Quality, and Lean Leadership.
The Senior Manager QA will be accountable for the following functions in support of core QC laboratory operations:
- End to end life cycle for QC equipment, including the procurement, development and execution of validation and change control strategy/ownership, oversight of general and preventive maintenance activities, and decommissioning.
- Lifecycle Management Program for ARI QC, OEM renewal, and budget approval.
- Site governance and corporate governance review and approval of new equipment project proposals.
Investigations & Supplier Quality Management (SQM):
- Quality oversight for QC operations, including Deviation, CAPA/EV, Change Control.
- Ownership of major deviations to understand product impact and investigate for root cause.
- Supplier quality management and raw material-related deviation events.
- Lead for Deviation and CAPA, quarterly trending, metric generation, management review and global network support.
Analytical & Quality Systems:
- Site SME's for Quality Control electronic systems including: Laboratory Information Management Systems (LIMS), Laboratory Method Execution System (LMES), Consumables Inventory Management Systems (CIMS), and Chromatography Data System (CDS).
- Ownership of minor deviations and CAPA/EV records.
- Quality oversight of Analytical Result Assessment (ARA) and major deviation records.
- Generation of laboratory/method performance metrics and key performance indicators (KPI's)
- Lead for sample plan management
Quality Control Leadership Team:
- Representation in governance, management review and other forums.
- Innovative projects to advance efficiency.
- Compliance with safety guidelines, cGMPs and other applicable regulatory requirements.
- Support staff training, career development and performance management.
- Establish LEAN principles across all areas of responsibility.
- Enable department goals, strategies and KPIs.
- Doctorate degree and 2 years of Quality experience
- Master's degree and 6 years of Quality experience
- Bachelor's degree and 8 years of Quality experience
- Associate's degree and 10 years of Quality experience
- High school diploma / GED and 12 years of Quality experience
- 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Experience managing staff and/or leading teams, projects, programs or directing the allocation of resources
- Excellent written and verbal communication skills, ability to work in a team matrix environment and build relationships with partners
- Supervise record of building or participating as a member of robust team
- Experience in auditing and defending processes, procedures and decisions during regulatory inspections
- Experience with various laboratory computer systems and applications
- Strong leadership and negotiation skills with a demonstrated ability to influence different styles
- Innovative thinking and ability to transform work organizations
- Strong technical writing skills within a highly regulated environment
- Exposure to Operational Excellence initiatives
- Detailed understanding of quality management systems and quality control processes related to bulk drug and drug product for clinical and commercial operations
- Proven ability to navigate through ambiguity and provide a structured resolution
- Experience with multi-functional project teams and deliver on schedule
- Previous experience with leading cross-functional teams
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.