Director Compliance and Auditing

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Requirements and Knowledge:

• BS in Natural Science (Chemistry, Pharmacy, Biology, Engineering or a related pharmaceutical science).

• Eight (8) years of progressive managerial experience within the quality control function of the pharmaceutical/health care industry and regulatory agencies, with 5 years of experience in aseptic filling and finishing areas for liquid and lyophilized products and medical devices.

• Ability to develop and apply BMS’s operating philosophy and to operate within Company policies and procedures within Manufacturing, Quality and Compliance, Marketing and Regulatory areas.

• Proficient in cGMP’s and FDA regulations and requirements.

• Experience in containment technologies.

• Understanding of the business and marketing aspects of pharmaceutical operations in a highly regulated industry is extremely important for evaluating the potential impact of product decisions.

• 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.

• Working knowledge in PC’s and electronic tools.

• Excellent communication skills in both English and Spanish.

Responsibilities:

• Provides direction and leadership to direct reports and other key managers at the site to enhance compliance of GMP systems, company policies and guidelines.

• Drives the establishment of systems and site culture in order to create sustainable regulatory compliance.

• Performs internal, external and walkthroughs audits to ensure regulatory compliance.

• Establishes the Strategy and Readiness activities for the inspection.

• Develops the responses to the regulatory agencies and track any commitment sent to the agencies, assuring the completion on time.

• Leads regulatory inspections, GCA Audits as well as Third parties inspections.

• Participates actively in the development, implementation and monitoring of the Internal Audits and Supplier Management Development Program.

• Liaison between the suppliers and the site.

• Ensures compliance in documentation systems and controls in accordance to CMC and GMP regulations.

• Provides direction and leadership to GMP training and lessons learned programs.

• Assures the proper management of customer complaints in accordance to company policies and directives.

• Develops the Site Master File and ensures the periodic update.

• Develops and leads the Monthly Quality Councils.

• Ensures site Risk Management Program.

• Participates actively in the preparation of the department budget and effectively manages company funds and actives Promotes and model the BMS Core Behaviors, facilitating teamwork, providing coaching, feedback etc.

• Supports all site Initiatives and any other assignments based on business needs. Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ&C Headquarters Policies and Directives.

• Ensures that deviations from procedures and specifications 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." Leads recalls, market withdrawals, and other regulatory actions when authorized by the Sr. Vice President Worldwide Quality & Compliance or as required by local regulatory agencies.

• Interfaces with Regulatory Agencies as necessary, participate in Regulatory inspections and ensure compliance with the marketing authorization requirements.

• Notifies the appropriate levels of management within Quality Operations Senior Management of significant quality issues in a timely fashion.

• Assures that all departments have knowledge regarding the roles, responsibilities and authority of the Quality Unit.

• Completes Annual Product Quality Review Report elements as established in products / systems schedule.

• Verifies consistency with other site procedures and/or specifications.

• Verifies compliance with BMS Policies and Guidelines.

• Reviews and approves all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR’s) elements.

• Support Lessons Learn and Process Knowledge Programs Manages Fact Finding Meetings Reviews supporting data for compliance with cGMP documentation practices.

• Ensures that there are systems in place to assure that personnel have adequate training, education and experience to perform their GMP related job functions effectively. Completes Annual Product Quality Review Report elements as established in products / systems schedule.

• Assures that the manufacturing and packaging procedures are properly followed and adequate for their use.

• Serves as a liaison with internal and external customers.

• Ensures that all current vendors are qualified and conduct audits of approved Third Party Manufacturers and other vendors at defined frequencies as part of the vendor monitoring process as part of the Supplier Management Program. Manages the product complaints that include performing complaint investigations in a timely manner, instituting corrective actions where appropriate and identifying product complaint trends.

• Responsible for the Inspection Readiness Program Ensures that recall operations are capable of being initiated promptly and at any time. This includes that lists are maintained of customers of all batches distributed and of distribution information."

• Manages support of SOPs, WFPs, and WPPs in the documentation management system." Facilitates the Quality Council by sponsoring and driving Quality Initiatives that directly impact the Site operations.

• Manages the Quality Agreements Management system. Provides support to Site Projects.

• Prepares and manages Annual Product Quality Reports Program Administers documentation management systems Creates, reviews, approves and track corrective actions related to internal and external audits.

• Ensures compliance with regulatory commitments

• Manages Field Alerts reports (FAR) and Biologic Product Deviation Reports (BPDR). Reviews and approves procedures related to regulatory commitments to assure that the procedures are properly followed and adequate for their use and verifies consistency with other site procedures and in alignment to regulatory commitments.

• Acts as the Liaison person for regulatory initiatives Supports product submissions.

• Manages Licenses renewals within the area of responsibility.

• Manages the Records Retention program within the functional area of responsibility.

BMS BL

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

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.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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