Senior Conformance Specialist

Title: Sr. Conformance Specialist 

Location: Berkeley, California, United States

Work Type: Hybrid

Job ID: 855845

Job Description:

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice.

PURPOSE

Senior technical professional responsible for investigating and resolving higher category discrepancies that occur in clinical and commercial biological manufacturing operations. This is a hybrid office-based/work-from-home position within the United States. 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

YOUR TASKS AND 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• 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 QUALIFICATIONS

• 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.

Employees can expect to be paid a salary between $118,896.00 to $178,344.00. Additional compensation may include a bonus or incentive compensation (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc..

This salary range is merely an estimate and may vary based on an applicant's location, market data/ranges, an applicant's skills and prior relevant experience, certain degrees and certifications, and other relevant factors.