Quality Assurance Senior Manager - Los Angeles CA
Quality Assurance Senior Manager - Los Angeles CA
Posted on :
23-06-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
23-06-2025
Job Description
ATTENTION MILITARY AFFILIATED JOB SEEKERS- Our organization works with partner companies to source qualified talent for their open roles. The following position is available toVeterans Transitioning Military National Guard and Reserve Members Military Spouses Wounded Warriors and their Caregivers. If you have the required skill set education requirements and experience please click the submit button and follow the next steps. Unless specifically stated otherwise this role is On-Site at the location detailed in the job post.
Lets do this! Lets change the world! Amgen is searching for a Quality Sr Manager site lead who will be responsible for Quality and Compliance oversight of contract manufacturing/testing sites. This Quality Sr Manager will have significant responsibility working with supplier quality and manufacturing.
The Quality Sr Manager will report into External Supply Qualitys North American regional team. This role can be filled in multiple locations in the United States.
Key responsibilities for this role include:
Be an integral quality partner of Amgens cross-functional external supply team that includes: business operations analytical sciences process development and supply chain.
Perform general oversight and periodic evaluations of Quality performance for contract manufacturing/testing sites.
Negotiate Quality Agreements (QAGR) and ensure adherence to QAGR terms.
Review and approve master batch records test methods deviations change controls CAPAs CAPAEVs and Product Complaints
Provide quality oversight of new product introductions tech transfers and process qualification activities at the contract manufacturing site
Provide data for Annual Product Review (APR).
Support audits/inspections (e.g. prepare topics to be presented during inspections). Support management of audit/inspection commitments to completion
Represent Amgen at product-specific regulatory inspections and/or during notified body audits of the contract manufacturing site.
Ensure inspection readiness (e.g. prepare playbooks participate in mock inspections)
Identify and mitigate risks at supplier site and raise to management as appropriate
Perform tactical batch disposition activities in support of lot release
Role may require occasional travel
Lets do this! Lets change the world! Amgen is searching for a Quality Sr Manager site lead who will be responsible for Quality and Compliance oversight of contract manufacturing/testing sites. This Quality Sr Manager will have significant responsibility working with supplier quality and manufacturing.
The Quality Sr Manager will report into External Supply Qualitys North American regional team. This role can be filled in multiple locations in the United States.
Key responsibilities for this role include:
Be an integral quality partner of Amgens cross-functional external supply team that includes: business operations analytical sciences process development and supply chain.
Perform general oversight and periodic evaluations of Quality performance for contract manufacturing/testing sites.
Negotiate Quality Agreements (QAGR) and ensure adherence to QAGR terms.
Review and approve master batch records test methods deviations change controls CAPAs CAPAEVs and Product Complaints
Provide quality oversight of new product introductions tech transfers and process qualification activities at the contract manufacturing site
Provide data for Annual Product Review (APR).
Support audits/inspections (e.g. prepare topics to be presented during inspections). Support management of audit/inspection commitments to completion
Represent Amgen at product-specific regulatory inspections and/or during notified body audits of the contract manufacturing site.
Ensure inspection readiness (e.g. prepare playbooks participate in mock inspections)
Identify and mitigate risks at supplier site and raise to management as appropriate
Perform tactical batch disposition activities in support of lot release
Role may require occasional travel
Additional Qualifications/Responsibilities
What we expect of you
We are all different yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of quality and compliance experience OR
Masters degree and 4 years of quality and compliance experience OR
Bachelors degree and 6 years of quality and compliance experience OR
Associates degree and 10 years of quality and compliance experience OR
High school diploma / GED and 12 years of quality and compliance experience
Preferred Qualifications:
Bachelors of Science degree
8 years biotech or pharmaceutical industry experience.
Significant Quality and/or Manufacturing experience at small and/or large molecule DS DP or FDP manufacturing facilities. Experience with synthetics/small molecules a plus.
Ability to facilitate and influence senior partners and balance workload and timelines
Ability to negotiate a strategic position after taking feedback from multiple sources.
Strong project management (PM) problem-solving and analytical skills and familiarity with PM tools.
Experience with analytical testing situations (e.g. method transfers analytical qualifications stability lab investigations in process testing release testing).
Shown ability to lead cross-functional teams consistently deliver timely and quality results.
A record of collaborating and communicating with others and the ability to balance divergent inputs from various partners while driving issue to resolution.
Ability to operate in a matrixed or team environment with site functional and executive leadership.
Skilled in using risk based decision-making approaches
Experience with the regulatory activities and variation management
Required Experience:
Senior Manager
Employment Type
Full Time
Key Skills
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