Associate Director QA Operations
BAYER - Berkeley, CA

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Bayer HealthCare (BHC), an Equal Opportunity Employer, makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women's Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear.

Bayer†s corporate culture is an important factor in the company†s success. Central to this culture are our values: Leadership, Integrity, Flexibility and Efficiency, summarized by the term LIFE. They provide us with guidance for our daily work as we seek solutions to the major challenges of our time, in line with our mission statement †Bayer: Science For A Better Life".
QA Operations
We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.

If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now.

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
1. Provide effective leadership including: selecting key personnel and motivating members of the functional area; assisting with Performance Calibration/Talent Pool Management; individual goal setting/performance reviews; managing the development of employees, training and development; supporting managers in team activities and Transition Workshops; supporting workforce diversity, quality and safety and supporting supervisors/managers in individual/department/business objectives.

2. Directs management of release and investigations in bulk, intermediates and final containers, and quality control. Drives timely
investigations and release, resolution of issues and implementation of
corrective/preventive measures using scientific principles, root cause
analysis and compliance minded corrective and preventative actions.

3. Maintains awareness of current GMP trends and manufacturing processes and assures employee representation in professional industry groups; Creates and drives continuous improvement within the Quality Unit.

4. Leads teams to provide highly scientific evaluation of issues
intended to mitigate business and compliance risk while maintaining
product supply of biopharmaceutical product with regard to strength,
purity, potency.

5. Is accountable for regulatory agency interactions, investigation
resolution at the Berkeley site and investigations on the global level
relating to rFVIII.

6. Ensures compliant resolution of production discrepancies related
to product release taking into account all manufacturing processes,
quality testing and customer requirements. Uses scientific judgment to
ask key questions during investigations intended to identify root cause
of issues.

7. Ensures product technical complaint resolutions are implemented
and aligned with the Local Quality Representatives of the affected
countries.

8. Ensures product release taking into account related production
discrepancies, status of related CCRs (incl. Compliance status) and
quality testing data (incl. data trending of critical process parameters
and critical quality attributes).

10+ years of experience in pharmaceutical or related industry or an
equivalent combination of education and experience. 7+ years of prior
management experience.

Experience in the biopharmaceutical or biotechnology industry is preferred. A mixture of Quality and Operations experience is preferred. ASQ certification is preferred.

  • Advanced knowledge and experiece in biopharmaceutical subject matter areas including: Manufacturing of bulk, intermediates and final containers; Product disposition and release; Discrepancy management; Product inspection and labeling; Aseptic processing; Environmental monitoring; Contract manufacturing, Internal auditing, and handling of Customer Complaints.
  • Broad cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international agencies).
  • Ability to streamline organization to maximize efficiencies to resolve discrepancies and trending issues. Must be able to make tough decisions under pressure including possible changes in organization structure of team.
  • Strong leadership and interpersonal skills.
  • Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives.
  • Excellent communication skills, good presentation and influencing skills
  • Ability to interact and gain the support of senior management
  • Ability to effectively manage multiple, complex priorities
  • Ability to work cooperatively in teams and peer relationships
  • Serves as a liaison with regulators, internal auditors or
external clients (e.g. Garbagnate, Shiga).

  • Ability to understand data sets and drive to compliant data based decisions.
Bayer is an Equal Opportunity Employer
Minorities/Females/Protected Veterans/Disabled

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For when you can't "bayer" the pain, Bayer Corporation makes your medicine. The US headquarters of pharmaceuticals and...