Bayer Sr. Manager QA Deviations API in Berkeley, California
Your tasks and responsibilities
Position Purpose:Lead a team of specialists responsible for evaluating and approving deviation investigations, CAPAs, and complaints, with adherence to Bayer directives/expectations to ensure patient safety and to protect the Bayer brand.
:Major tasks and responsibilities of position; Provide effective leadership including: individual goal setting/performance reviews, managing the development of employees, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, selecting personnel and motivating members of the functional area; supporting workforce diversity, quality and safety and supporting supervisors in the management of their employees/department which support achievement of individual/department/business objectives Supports the management and oversight of discrepancies in API, bulk, intermediates, drug product, quality control, and complaints to assure: timely investigations, resolution of issues, and implementation of corrective/preventive measures using root cause analysis with scientific principles and compliance minded actions - Prepares SOPs and investigation documents; tracking and trending analysis and KPI’s relevant to business process - Resolves production discrepancies and customer complaints as related to product release, which must take into account all manufacturing processes, quality testing and customer requirements. Must use scientific judgment to ask key questions during investigations intended to identify root cause of issues. Requires ability think calmly under pressure and to influence team members to arrive at decisions which may be difficult or unpopular. - Uses resources across sites and across departments to achieve strategic objectives. 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, and potency. - Maintains awareness of current GMP trends and manufacturing processes and supports continuous improvement within the Quality Unit. - Provides support for regulatory agency inspections and requests - Provides expert opinion related product safety taking into account related production discrepancies, status of related change control and quality testing data (incl. data trending of critical process parameters and critical quality attributes).
Who you are
Required qualifications: Your success will be driven by your demonstration of our LIFE (Leadership, Integrity, Flexibility, and Efficiency) values. More specifically related to this position, Bayer seeks an incumbent who possesses the following: - Bachelor’s degree in scientific discipline, i.e Chemistry, Pharmacy, Biotechnology, etc. - BS 7+ years of experience - 5+ years of experience - Previous experience leading people Or an equivalent combination of education and experience - 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 - Broad cGMP experience and knowledge, QA/QC and regulatory compliance (US and other international agencies). - Ability to streamline business processes to maximize efficiencies to resolve discrepancies and trending issues. Must be able to make tough decisions under pressure and be able to adapt to changes in organization structure. - 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.
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. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer Minorities / Females / Protected Veterans / Disabled