Prin QA Validation Scientist, Manager of Change Management

Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.Berkeley, California is a multi-functional Bayer HealthCare site that houses the global headquarters for the Specialty Medicine business units, the headquarters of the global biotech product supply organization, and one of three major global R&D sites focusing on protein therapies. In fact, Berkeley is essentially the nerve center of Bayer HealthCare's biotech operations. With a focus on biopharmaceutical discovery, development, manufacturing, and commercialization, we believe our ability to advance improvements and innovations in patient care will be greatly enhanced by our fully integrated capabilities.POSITION DESCRIPTIONThis position manages the Change Management department within the Quality Function PS-Biotech. The incumbent develops, implements, and manages a sustainable core quality system to support operations, in partnership with Corporate Quality Assurance. Ensures changes to products, facilities, utilities, equipment (laboratory and production), computer systems, and analytical methods are maintained in a licensed state through assessment, using the life-cycle approach. Establishes priorities, determines equipment and manpower requirements to meet the business requirements for change implementation. Maintains clear, detailed records of change control activities. Plans, controls, reports, and resolves issues with the quality system to assure product and process quality.-Manages Change Management Department activities, which include: determination of priorities, and the evaluation and continued professional development of staff.-Manages the development and implementation of Change Management standards and systems, in accordance with regulatory requirements, current Good Manufacturing Practices (cGMPs), and Bayer policies and procedures. This system must assure that all regulated cGMP activities continue to comply with Bayer licenses in each country of product distribution or clinical trial after any changes are implemented. Serves as a key interface for Supply Center Berkeley with the Global Change Management functions.-Interfaces with management to set QA policies on product quality to assure adherence to standards.-Manages the development of cost effective approaches to Change Management in keeping with current industry practice and agency expectations.-Accountable to hire and maintain a high level of qualified and competent staff. Responsible for professional development of staff and performance management process, including promotions. Ensures that Quality staff participate in continuous cGMP training. Assures and maintains harmonious relations with employees and other departments to maintain high employee morale.-Determines, interprets, defines and implements the acceptance criteria, specifications, and standards for each change activity.-Approves Change Applications and final packages for the facilities, utilities, computers, cleaning, equipment, processes and specifications.-Generates Change Management summaries and defends Change Management approach with regulatory authorities during inspections and submissions to the agencies.-Accountable to manage data input to the Quality Management Control and Reporting System (MCRS).-Monitors and maintains a database to track the status of Change Management activities. -Maintains the QA Reviewer and Approver Matrix for Change Applications-Report on Change Management data for the Annual Product Review.-Approves Quality Assurance and production procedures to ensure plant operations conform to current cGMP regulations. The activities of this position impact on the licensing of products and their availability in the market-Accountable to develop training content and support delivery of site training in validation and change control procedures. -Handles conflicting priorities effectively communicating with personnel of diverse scientific and technical backgrounds.-Serve as a resource to other departments within PS Biotech division, and to groups outside the PS-Biotech, on issues of product quality. Coordinates resources within Quality and other units to assure that project requirements are met. Assures the representation of the QA Function and in the appropriate industrial associations to maintain an awareness of trends in the associated industry with respect to Quality Assurance and manufacturing practices.Commitment to health, safety and protection of the environment: The incumbent supports Bayer BP Berkeley’s commitment to safety by complying with the programs regarding health, safety and protection of the environment. The incumbent demonstrates safe work practices, takes part in safety meetings as required, and advises relevant personnel (e.g. supervisor, etc.) of any non-conforming conditionsPOSITION REQUIREMENTSBS plus 8 years of relevant experience;MS plus 6 years;PhD plus 4 yearsSpecial Requirements: -A well-rounded technical background encompassing engineering, instrumentation, computerized systems, biology, chemistry, microbiology, statistics and thermodynamics is desirable. -Familiarity with all aspects of pharmaceutical validation is required. Requires independent judgment and responsibility for complex technical problem solving-Knowledge of cost control-Ability to assess employee performance and provide constructive feedback. -Ability to lead, develop and maintain good working relationships with employees from diverse backgrounds.-Familiarity with the use of personal computers and various software packages used in communications, presentations and technical analyses of data.-Familiarity with worldwide government regulations to meet the requirements of various countries..