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Sr Specialist - QA Discrepancy Management - Berkeley, CA 

Sr Specialist - QA Discrepancy Management – Berkeley, CA

Purpose

Evaluate and approve incident reports (IRs) [discrepancies] and corrective and preventive actions (CAPAs) using scientific principles, thorough analysis, and compliance minded thought processes which meet cGMP requirements within established timelines.

YOUR TASKS AND 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

REQUIRED QUALIFICATIONS

• 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 QUALIFICATIONS

• 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.

Employees can expect to be paid a salary between $115,420.00 to $173,130.00.  Additional compensation may include a bonus or commission (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.

This posting will be available for application until at least 5-15-25.