Bayer · 23 hours ago
Sr Specialist - QA Discrepancy Management - Berkeley, CA
Berkeley, CA
Full-time
Onsite
Senior Level, Lead/Staff
$115K/yr - $173K/yr
8+ years expBayer is a global company committed to addressing the world's challenges in health and agriculture. The Sr Specialist - QA Discrepancy Management will evaluate and approve incident reports and corrective actions while ensuring compliance with cGMP requirements, leading teams, and driving continuous improvement efforts.
BiotechnologyChemicalHealth CareLife SciencePharmaceutical
Responsibilities
Represent QA in interactions with Quality Assurance, Quality Control, Technical Operations, and Supply Chain, Bayer partners, Supplier Auditors/Inspectors, regulatory agency inspectors
Review and approve incident reports and CAPAs Ability to enter, review, query, and trend data in electronic discrepancy management systems (e.g. TrackWise)
Use resources across site and across departments to assure timely investigations of high quality
You may lead teams to provide highly scientific evaluation of issues intended to mitigate business and compliance risk while maintaining product supply. Manages non-routine projects of moderate to high complexity
Provide effective leadership in training and developing internal customers/stakeholders
Support workforce diversity, quality and safety
Write and revise SOPs. Supervise and provide technical guidance to Technical Reviewers
Monitor processes and products to identify opportunities for continuous improvement
Qualification
Required
Bachelor's degree in a scientific/ technical field
Significant experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations
Multiple years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience
Must be able to understand, review and approve incident reports (discrepancies) and CAPAs
Proven ability as a team player and leader
Excellent interpersonal skills
Must be able to listen and understand the opinions and perspectives of others while influencing without authority with internal and external customers/stakeholders regarding possible recommendations
Proven ability to lead cross functional teams
The ability to independently recognize opportunities and the need for business and process improvements
The ability to multitask and support changing priorities
Strong written and oral communication skills, good presentation and influencing skills
Ability to assess, investigate and resolve deviations
Strong ability to plan and prioritize complex and conflicting objectives to meet release goals and manage multiple priorities
In depth knowledge of GMP
Preferred
Advanced degree
Over 8 years of overall experience in the biopharmaceutical, biologics, medical device or related industry, along with knowledge and understanding of cGMP concepts, and applicable US and foreign regulations
Over four years of direct experience in Manufacturing and/or Quality in a GMP-regulated industry or an equivalent combination of education and experience
Benefits
Health care
Vision
Dental
Retirement
PTO
Sick leave
Company
Bayer
Bayer is a life science company that specializes in the areas of health care and agriculture.
10001+ employees
H1B Sponsorship
Bayer has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (62)
2024 (71)
2023 (76)
2022 (141)
2021 (138)
2020 (117)
Funding
Current Stage
Public CompanyTotal Funding
$9.34BKey Investors
Bank of AmericaBill & Melinda Gates FoundationTemasek Holdings
2025-09-26Post Ipo Debt· $331.5M
2024-12-06Post Ipo Debt· $5.29B
2022-11-08Grant· $12M
Leadership Team
Wolfgang Nickl
Member of the Board of Management of Bayer AG and CFO
Abi Abitorabi
VP, CGT Platform Implementation Lead
Recent News
Morningstar.com
2026-01-20
2026-01-20
Company data provided by crunchbase