Senior Manager, Quality Control New Product Introduction & Investigations

Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.Position SummaryIn this role you will lead the New Product Introduction & Investigations team within the Quality Control (QC) department. This position will develop strategic plans and work cross-functionally to accomplish method transfer and/or validation activities, Trial material assessment and QC Deviations/Investigations on time completion and compliant to Bristol Myers Squibb standards. You will be responsible for cGMP compliance of the laboratory area and operations under your responsibility as well as for applying and ensuring staff complies with Environmental Health & Safety applicable procedures. The Sr. Manager QC New Product Introduction & Investigations reports to the Director Head of Quality Control.Key ResponsibilitiesManage team and ensures cGMP compliance of the laboratory area and operations under their responsibility.Create a positive and collaborative team environment and or ensure that Bristol Myers Squibb standards are met.Manages performance and provides technical guidance, coaching and support to team members.Assigns training requirements and monitors training status of assigned team members.Ensures all equipment used for GMP testing is in a qualified state.Can approve laboratory investigations, checklists, and deviations as SME/Area Manager.Authors, reviews, and approves complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports.Support and sustains Lean Lab initiatives such as 5S, deviation reduction, Right First Time, and inspection readiness.Actively participates in inspections by Health Authorities.Create metrics to monitor schedule progress and help identify risk areas.Supports budget definition and adherence to budget target.Create team plans to ensure resources are properly allocated and utilized effectively.Represent QC in New Product Introduction meetings and others as assigned.Ensure management of reference standards as per internal procedures.Lead QC activities pertaining to new methods and new product/material introductionsAs receiving unit, assess impact on laboratory systems, processes, safety, training, and resource planning.Ensure laboratory readiness and timely execution of method transfers, validations and/or verification.Lead writing of technical reports.Maintain Acceptance Residual Limit evaluation for QC and transfer and/or validate cleaning analytical methods as required.Oversee QC trial material assessment process and/or ensure collaboration with QC Incoming Material, QC Commercial Drug Product and other cross-functional teams on testing requirements and sampling plans.Timely and appropriately escalate issues requiring management decision and impacting resource allocationRepresent QC in cross functional teams meeting and report QC progress and risksManage Deviations and InvestigationsAct as Deviation Owner and/or Lead Investigator for QC deviations/investigations requiring a formal root cause analysis.Work cross-functionally with impacted QC areas to define appropriate and effective corrective and preventive actions (CAPAs).Ensure timely and compliant closure of QC deviations/investigations and CAPAs according to Bristol Myers Squibb procedures.Escalate issues requiring management decision in a timely manner.Provide appropriate level of reporting and communication on the assigned deviation/ investigations at Quality governance forums.Present deviations in audits conducted by regulatory agency representatives.Assure proper definition of CAPAs.Support with data/analysis requests for investigations/deviations.Authors, reviews, and approves complex GMP documentation such as standard procedures, work practices, training plans, and reports as result of deviation/investigation.Support QC Commercial Drug Product and Incoming Material TeamsCollaborate cross-functionally to define testing priorities, assign work to team members, and monitor progress against schedule.Review and approve documentation as required by laboratory proceduresMight perform final approval and disposition of QC results, as applicable.Provide technical support to QC team members.Support to identify training gaps and development of training content.Work with QC leadership to identify and procure equipment.Promotes safe practices and behaviors.Report immediately incidents to Environmental Health and Safety (EHS) department, participate in investigations and identify measures to prevent similar accidents in the future.Ensures that staff (including short duration and temporary contracts) is properly informed on hazards and trained to act in consequence.Promotes safe practices and behaviors, assure that EHS requirements are implemented and respected.Demonstrate Bristol Myers Squibb values.Performs other tasks as assigned.Qualifications & ExperienceEducation and ExperienceBS or advanced  degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience.Minimum 8 years of work experience in a GMP environment (pharmaceutical industry or similar field) or 5+ years with advanced degrees.Quality Control Laboratory management experience a must.Exceptional scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques).Exceptional experience with chemistry testing of solid oral dosage forms.Extensive knowledge on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.Required Competencies:  Knowledge, Skills, and AbilitiesSubject matter expert of Quality Control activities in the pharmaceutical industry with strong knowledge and interpretation of cGMP and regulations applicable to the Quality Control environment, specifically Method Transfers and Validation.Knowledge of Data Integrity and Good Documentation Practices.Ability to accurately understand, follow, interpret, and apply European Pharmacopeia and United States Pharmacopeia requirements and cGMP requirements.Exceptional technical writing skills.Work to improve efficiencies through process improvementsIndependent, adaptable, and highly motivated.Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities.Understand how to collaborate with a variety of different people and roles.Communicate effectively with direct reports, peers, and management.General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)Fluent in English or French and professional command of the second language (written and verbal)If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as “Transforming patients’ lives through science ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.