Associate Director QA Operations

Job Title
Associate Director QA Operations

Job Description
Bayer is a global enterprise with core competencies in the fields of health care, agriculture and high-tech polymer materials. As an innovation company, it sets trends in research-intensive areas. Bayer’s products and services are designed to benefit people and improve their quality of life. 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 Divisions include Specialty Pharmaceuticals, Medical Care, Consumer Care and Animal Health. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Associate Director QA Operations
QA Operations Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now.
Your Tasks and Responsibilities
• 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.
• 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.
• 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.
• 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.
• Is accountable for regulatory agency interactions, investigation resolution at the Berkeley site and investigations on the global level relating to rFVIII.
• 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.
• Ensures product technical complaint resolutions are implemented and aligned with the Local Quality Representatives of the affected countries.
• 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).

Who You Are
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 experience 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

Desired Skills and Expertise
Bachelor's Degree

Industry
QA

Experience
5+ years

Job Type
Full Time

Salary / package
Not Specified

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