Manager, Quality Control Laboratories
About the Job
This position is responsible for managing QC- Analytical and Bio-analytical laboratories activities on the site. The incumbent will be responsible for managing chemical testing of raw material, in process, combination products and finished product testing. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Performs in accordance to the implementation of laboratories goals, objectives and mechanisms to ensure the optimum operational, financial and regulatory performance of the chemical testing laboratories consistent with departmental and site strategies, SOPs and WWQ&C policies. Oversees analytical testing of raw materials, finished products, USP water and cleaning samples. Supports validation activities of the site ensuring analytical testing of validation samples is performed as required time frame. Coordinates administrative activities, ex. Scheduling and lab utilization performance, HR issues, budget, hiring, performance partnerships, etc. Provides technical/scientific leadership, expertise and guidance to the site QC Chemistry staff to ensure timely completion of goals and objectives in accordance to performance indicators. Manages performance upon site and laboratory projects and determines resource constraints when necessary. Ensures that site QC Laboratories staff receives training in appropriate procedures and protocols, including safety, cGMP training, etc. Overall, assures compliance with all accepted laboratory and safety procedures. Ensures that the QC laboratories personnel have the required materials, equipment and tools to support site operations. Participates on project teams to ensure that laboratories representation is provided on technical issues. Supports analytical technology transfers. Assures that data and reports generated by direct reports are consistent and accurate. Supports Analytical Development staff in assuring that existing laboratory methodology at the site is robust and that validation is maintained within BMS guidelines. Interfaces with other BMS groups in GPS on project issues to build collaboration and harmonization within the development and manufacturing network at BMS. Ensures that all activities are performed in compliance with federal and local regulatory agencies (e.g., OSHA, EPA, FDA, etc.). Maintains a safe work environment for Chemical laboratories. Interacts and supports inspections and regulatory submissions with regards analytical and microbiological laboratories matters. Ensures that deviations associated to laboratory, OOS’s, etc. are investigated, resolved and documented, that corrective / preventive actions are identified and implemented to avoid the occurrence/recurrence of deviations and that no materials are released before the completion of the investigation. Notifies the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion. Ensures that all Quality Control (QC) personnel involved in chemical testing of finished products, API’s, raw materials, intermediates/components, and USP water have approved, validated methods and specifications, robust systems and adequate facilities to perform required testing. Ensure all necessary testing is carried out. Assures that the QC laboratories equipment and personnel are formally qualified before release testing of products/materials is performed. Administer and provide all the analytical information to support the Annual Product Quality Review Report elements as established in products/systems schedule. Verifies compliance of the laboratories with BMS Policies and Guidelines. Reviews and approves lab instrumentation, utilities and facilities qualification and labs system life cycle documentation. Supports Method and Product Transfer initiatives. Reviews supporting laboratory data for compliance with cGMP documentation practices. Serves as a liaison with internal and external customers. Approves/rejects specifications impacting drug products, and/or raw material.Qualification: Bachelor’s Degree in Chemistry or equivalent field (Chemical Engineering may be applicable). Eight (8) years of progressive managerial experience within the quality control function of a pharmaceutical/health care industry and regulatory agencies, with at least three (3) years of experience in chemical analytical laboratory. In depth scientific knowledge related to analytical/bio-analytical sciences. Knowledge in chemistry/analytical instrumentation and techniques. Strong leadership skills. Proficient in cGMP’s and FDA regulations and requirements. Excellent interpersonal skills. Working knowledge in PC’s and electronic tools. Excellent communication skills in both English and Spanish. A systematic decision maker, assuring decisions are fact based and clearly documented. Planning skills. Excellent analytical and problem solving skills. Excellent verbal, written and presentation skills and have the ability to deal effectively with all levels of management. Must be innovative and creative and utilize all available resources. Willing to work irregular hours, rotating shifts, weekends and holidays.