Bayer · 7 hours ago
Sr. Conformance Specialist - Berkeley, Ca - Hybrid
Berkeley, CA
Full-time
Hybrid
Mid, Senior Level
$119K/yr - $178K/yr
6+ years expBayer is a company dedicated to solving global challenges, striving for a world where health and hunger are no longer issues. They are seeking a Senior Conformance Specialist responsible for investigating and resolving discrepancies in clinical and commercial biological manufacturing operations, ensuring compliance and continuous improvement in processes.
BiotechnologyChemicalHealth CareLife SciencePharmaceutical
Responsibilities
Investigate complex and Critical-level discrepancies using root cause analysis (RCA) methodologies. Recommend corrective/preventative actions (CAPAs) based on root cause investigations to eliminate recurrence
Communicate with all levels of employees to assure that the root cause, product impact, and cause(s) for discrepancies are adequately investigated and the report is completed
Lead multi-discipline teams to complete investigations, or for the purpose of Continuous Improvement
Determine the breadth of discrepancies and ensure appropriate Stakeholders in other organizations are made aware of a potential similar issues in their areas
Influences direction of investigations and communicates with all levels of employees. Write concise, accurate and effective discrepancy reports that meet compliance expectations
Generate appropriate written documentation to support rationale/justification for decisions made regarding potential impact/risk and product disposition
Use the Discrepancy Management system/database and RCA tools at an expert level to perform comprehensive investigations, data entry and data mining
Maintain Conformance KPI information and other metrics for daily DR record management
Ability to independently facilitate meetings and guide decision making
Ability to work independently in managing all aspects of investigations
Maintain knowledge of current regulatory practices including a current understanding of USP/EP, cGMP regulations, ICH, and FDA Guidance Documents. Provide support during internal/external audits
Ability to expand capabilities across operations support team (i.e., Conformance, Process Monitoring and GMP Projects) and other areas of biologics manufacturing activities, as necessary
Trains and provides on-going coaching and guidance for junior specialists
Qualification
Required
Bachelor's Degree in a scientific or technical field, preferably biological sciences or engineering
The employee may work remotely when consistent with business requirements but must come to work at the Berkeley site to support key tasks/project execution as determined by the Company and business needs. The allocation between remote and on-site work may change over time and requires the ability to be present at the site with minimal notice
Solid and broad understanding of pharmaceutical operations within commercial and clinical manufacturing, QC (environmental and product monitoring and sampling, assays, specification setting), Supply Chain and Warehouse Management, Validation, and Quality Systems (Deviation and CAPA management, Change Control, Audit & Observation management, Risk Management, etc.)
Expertise in cGMP and regulatory requirements (FDA, EMA, ICH, etc.)
Expertise in performing investigative work
Knowledge and hands-on experience with pharmaceutical manufacturing processes, including equipment, utilities, and facilities, cGMP compliance, high purity water systems, HVAC systems, process instrumentation, and control systems, etc
Strong technical writing skills and ability to coach others in writing for regulatory audiences
Strong analytical skills to identify root causes and prepare balanced decisions
Ability to successfully involve management of cross functional teams or significant resources
Ability to communicate with cross-functional partners to satisfy compliance requirements and meet production goals, while resolving discrepancies
Proven ability to build sustainable partnerships to collaborate internally, externally, and cross-functionally to build relationships, influence, persuade, recommend, and implement strategies, processes, and procedures
Excellent verbal and written communication skills including a proven ability to write concise, accurate, and effective discrepancy report for investigations that meet compliance expectations, as report writing is a key aspect of the position
Demonstrated integrity and a firm commitment to company belief and values. Treats others with transparency, fairness, and respect
Comfortable utilizing a variety of computer systems and applications, demonstrating the ability to streamline and enhance productivity through effective digital integration. Proficient/experience using Microsoft 365 (Teams, SharePoint, PowerPoint, Excel, Word, Visio, PowerBI), SAP, MES, JMP, Veeva, ValGenesis, Discoverant, and project management tools, or similar applications
Must meet Occupational Demands/Physical Requirement checklist
Ability to enter production, laboratory and engineering spaces safely
Preferred
Bachelor's degree with 8+ yrs', Master's degree with 6+ yrs, or Ph.D. with 3+ yrs of pharmaceutical and/or biotechnology experience including GMP manufacturing, deviation investigation, process monitoring, project management and validation experience or an equivalent combination of education and experience
Knowledge/experience conducting risk assessments, authoring/reviewing documents for regulatory review, health authority and/or internal audit participation, Lean six sigma, and continuous improvement methodology
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
2025-12-30
2025-12-29
2025-12-27
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