Manager, Compliance

Working with Us Challenging. 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: Manager, Compliance Location: Manati, PR. Key Responsibilities Assures the site quality systems are in place to avoid any possible regulatory compliance situation at the Site. Manages the different quality systems and programs established at the site such as but not limited to Change Control, Product Quality Complaints, Self-Inspection Audits, Document Control, External Audits, Quality Agreements, Supplier Qualifications, Annual Product Quality Review, Site Inspection Readiness, and others as assigned. Prepares Annual Product Quality Reviews report for each pharmaceutical finished packaged and bulk drug products manufactured at the Site as per established timelines. Conduct audits to suppliers and GMP Services Providers in support of the Supplier Management Program Reviews and prepares regulatory documentation intended for government regulatory agencies (e.g. FDA), such as site master files, new and existing product registrations, regulatory submissions, foreign countries registrations, certificates, etc. Reviews, evaluates and approves plant operating documents such as SOPs, change control, qualification reports, Protocols, CAPA, and process deviation investigations and maintains documents in an organized and traceable manner. Evaluates specifications, documents, protocols, registrations and recommends actions to assure regulatory compliance. Provides assistance in managing all aspects of regulatory and corporate inspections and participates actively during inspections and audits including performing readiness exercises before and during inspections/audits. Evaluates and recommends lots to be placed on stability, evaluate trends, and performs investigations when required. Ensures compliance with procedures, policies and directives to avoid regulatory issues performing Gap Analysis on BMS documents and observational findings from the pharmaceutical industry. Provides advice and service to all operating departments to assure compliance with cGMP’s and other regulations. Investigates product quality complaints, issues the corresponding reports indicating possible root cause and recommending solutions. Conducts and/or prepares training materials on GMP topics. Conducts formal Self-Inspection audits and pre-approval inspections following annual site plan with respective reports and actions items from areas impacted during the audit. Ensures the site has a self-inspection audit program and that all system audits are conducted at a specified frequency. Create, review approves and track corrective actions related to Self-Inspections and external audits Generates, reviews and implements procedures and forms to assure compliance with current practices and GMP Trends. Provide guidance and support on the transfer and introduction of new proucts and processes to the site to maintain quality and compliance Coordinate Fact Findings documentation following Global Quality requirements Support issuance of NDA Field Alert Reports and recall investigations. Provide support in the preparation of the monthly Quality Council Meeting, including support to gather and / or calculate metrics. Develops impact assessments related to Policies and Directives implementation. Ensure Global Quality policies and procedures are implemented in a timely manner, following pre-established schedule. Ensures that all current vendors are qualified and conduct audits of approved vendors at defined frequencies as part of the vendor monitoring process as part of the Supplier Management Program. Create, evaluates, follow up and approves change controls, including interactions with Global support areas, other BMS sites and third parties. Ensure change controls are created according to local SOPs and Global Quality requirements. Provide input into change control program management to assure all requirements to complete a change control are properly established and that no requirements are missing. Provide support to local and global projects, act as liaison for regulatory activities and provide guidance for gaps identified and determine potential remediation activities. Qualifications & Experience BS degree (Engineering, Pharmacy, Chemistry, Biology). Minimum Five (5) years of experience in the pharmaceutical industry for oral dosage manufacturing . Broad knowledge of cGMP governmental regulations and guidelines, and the ability to interpret and apply them . Ability to communicate effectively with wide range of personnel, written and verbal. Fully bilingual (Spanish/English) writing and speaking. Solid technical writing and interpretation skills related to investigations, process & equipment validations/qualifications, computer system validations, Regulatory Filings, and customer complaints. Ability to create / organize cGMP systems and procedures based on regulatory compliance requirements . Knowledge to conduct and lead GMP Audits (internal and external) and regulatory inspections. Working Conditions Minimum exposure to hazardous areas is required. Exposure may occur when evaluating damage drums received in the Warehouse. Travel to visit other facilities, parent or outside companies, suppliers and/or attend seminar. Varies depending on the situation may be in the average of one week per year.
LI-Onsite BMSBL 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 Careers With 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 Protocol Physical 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. COVID-19 Information To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. 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.