Sr. Manager, Investigation Program Quality Systems Details

Sr. Manager, Investigation Program Quality Systems

Bristol Myers Squibb - Manatí Municipio, PR

Employment Type : Full-Time

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.

Incumbent support the site’s Investigation and CAPA Programs to ensure it meets regulatory and industry expectations and has appropriate understanding of risk. Support the communication of the program’s vision and progresses its sustainability by facilitating governance for the program to deliver per expectations by driving for continuous improvement and designing and developing countermeasures to address deficiencies at a program level. This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Major Duties and Responsibilities:
1. Ensures robustness and approves investigations and process deviations or incidents where quality standards of a product or its validation may be questionable. Provides guidance and recommendations as to future course (s) of action.
2. Ensures sound discussions on training adequacy and CAPA effectiveness.
3. Support data trending and demonstrates a healthy (robustness) of the investigation program.
4. Drives for continuous improvement and develops countermeasures to address deficiencies at investigation program level.
5. Facilitates the governance of the investigation program to address all above responsibilities.
6. Maintains communication with internal & external customers to ensure compliance & timely completion of investigations activities.
7. Support the Quality Assurance investigation function during FDA, corporate GMP’s and customer’s compliance audits.
8. Reviews and approves the standard operating procedures.
9. Supports the QC/QA efforts during the transfer and validations of parenteral products at the site.
10. Assures the compliance of the following processes required and activities: implementation of corporate policies, guidelines and new regulatory requirements, manufacturing of clinical and stability lots in accordance with cGMPs, corporate and regulatory guidelines, compliance of release/commercial product with the regulatory guidelines, BMS policies and cGMPs and procedures for evaluating lots records are in place.
11. Alerts site and headquarters management and take appropriate action in the event of a major operational event or incident, which affects cGMP, BMS policies or regulatory compliance.
12. Participates actively in the preparation of the department budget and effectively manages company funds and actives
13. Promotes and model the BMS Core Behaviors, facilitating teamwork, providing coaching, feedback etc.
14. Supports all site Initiatives and any other assignments / project based on business needs.
15. Notifies the appropriate levels of management within Quality.
16. Operations Senior Management of significant quality issues in a timely fashion.
17. Verifies consistency with other site procedures and/or specifications.
18. Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
19. Reviews and approves all executed batch production records and laboratory testing records before release of the product for distribution to assure that no deviations have occurred, or if deviations have occurred, that they have been fully investigated.
20. Ensures effective process /system for disposition of finished products & involvement in the decision for drug products disposition.
21. Supports the resolution of product and process issues associated to Quality Events and Method Transfer initiatives.
22. Reviews supporting data for compliance with cGMP documentation practices.
23. Approves or reject procedures impacting drug products, raw material or packaging components.
24. Verifies compliance with BMS Policies and Guidelines and participates as quality representative or liaison in site projects
25. Reviews and approves investigations related to process, products, utilities, microbiology laboratory and calibrations.
26. Approves Corrective and Preventive actions (CAPA’s). Serve as a mentor to junior investigators.
27. Ensures that an effective system for returns and salvages that include assessment, investigation and disposition is in place.
28. Provides support in the generation of site Key Quality Assurance performance and trending metrics.

• BS or master degree in Natural Science (Chemistry, Pharmacy, Biology, Engineering or a related pharmaceutical science). Master’s Degree in Science preferred.
• Eight (8) years of progressive managerial experience within the quality assurance 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. observations
• Demonstrated critical thinking skills
• Excellent technical writing and presentation skills

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.