Sr Director, Site Quality Head Phoenix

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.

Knowledge and requirements:

• At least 10 years of experience in Quality Assurance and/or Quality Control in a pharmaceutical company or other related industry.

• Master’s degree in Pharmacy, Chemistry, Microbiology or related science or equivalent experience.

• Solid understanding of Oral Solid Dosage, Recombinant, and Sterile products manufacturing, packaging, testing, warehousing processes and validation.

• In-depth knowledge of and thorough understanding of cGMPs and FDA; EU, and Swiss compliance standards, regulation, and guidelines.

• Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution.

• Excellent interpersonal, collaborative and organizational skills.

• Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives.

• Strong leadership skills for the management of large teams.

• Knowledge of most common office software and of IT-principles

Major Duties and Responsibilities

• Strategically shapes, develops, and directs all aspects of site quality programs, systems, operations and compliance activities, including, Quality Control, Compliance, Quality Assurance, and Quality Engineering. Serves as key member of the Site Leadership team contributing to site strategy, operational plan, and people strategy.

• Serves as key member of the Internal Site Quality Leadership team translating quality change initiatives into operating plans for the site.

• Ensures that appropriate GMP Quality Systems are in place, both through review and approval of procedures and shop floor presence, as required, and that adequate documentation exists to support and drive compliance.

• Ensures site GMP required procedures are in alignment and compliance with BMS Corporate Compliance and WWQ&C Headquarters Policies and Directives and verifies consistency with other site procedures and/or specifications.

• Ensures adherence to the Quality Unit responsibility (WWQC 2.1 current version) and provides leadership accordingly.

• Ensures that deviations from procedures and specifications are investigated, resolved, and documented; those corrective/preventative actions are identified and implemented to avoid the occurrence/recurrence of deviations and that no materials are released before the completion of the investigation.

• Lead 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 (FDA, EMA, and foreign regulatory agencies) as necessary, leads site regulatory inspections and ensure compliance with the marketing authorization requirements. Interfaces directly with suppliers and customers, as well as Global Product Development and Supply senior management.

• Notifies the appropriate levels of management within Quality Operations Senior Management of significant quality issues immediately and develops strategy and directs resolution with a cross-functional team.

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

• Ensures an effective process/system for disposition of raw materials, API’s, packaging and labeling materials and the involvement in the decision for Bulk Drug Substances disposition.

• Chair the site Quality Council in conjunction with the General Manager and anticipates regulatory trend and establishes systems to adhere to GMP compliance for the site and Company.

• Monitor implementation plans for any new Quality Policies, Directives and associated impact assessments and verify compliance with BMS Policies and Guidelines.

• Ensures that all incoming personnel have adequate training, education, and experience to perform their GMP related job functions effectively.

• Issue/approve/communication of Field Alerts and Biological Drug Product Reports per established timelines.

• Ensure the appropriate information to and obtain the Qualified Person’s approval as required by the specific European Union (EU) regulatory authorities is provided.

• Ensure that 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 are revised and approval.

• 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.

• Ensure manages the product complaints that include performing complaint investigations in a timely manner, instituting corrective actions where appropriate and identifying product complaint trends.

• Exercise sound judgment in making decisions and recommendations within generally defined practices and policies and notify senior management when necessary. Works on abstract problems across functional areas of the business. Identified and evaluates fundamental issues for major functional areas through assessment of tangible variables.

• Ensures that qualification/calibration of laboratory equipment is conducted following applicable procedures.

• Ensures budgets development and the preparation of periodic projections of spending against budgets; and manages and controls departmental spending.

• Direct involvement in securing regulatory filings of a facility or process and supports product submission documentation

Travel required:

This position requires approximately 5% travel to regional and /or headquarters.

BMSBL

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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