Manager, Quality System Investigation
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-usPosition: Manager, Quality System InvestigationLocation: Manati PR
- Acknowledge, review and/or approve site investigations and CAPAs including their correlated Corrective Actions and Preventive Actions (CAPA).
- Maintains communication with internal & external customers to ensure compliance & timely completion of investigations activities. Reviews investigations related to process, products, utilities, microbiology laboratory and calibrations.
- Supports readiness of the facility for Regulatory Inspection. Assists the Senior Manager during regulatory agencies inspections such as FDA / EMEA and/or during internal company audits. Documents any FDA communication between Site and agency.
- Prepares, submit and discuss reports of assigned Quality Systems status for trending and evaluation to the site management. Provides site GMP training based on annual requirements and support and training to other departments to ensure quality compliance as needed.
- Generates, reviews and implements departmental procedure and forms to assure compliance with current practices or GMP’s trends.
- Assures that site complies with Corporate Systems by evaluating, implementing and enforcing the company policies and guidelines.
- Ensures that Quality and Compliance is implemented in laboratory and operational areas and maintains it according with regulatory agencies expectations.
- Manages document including record retention program, compliance and custody of SOP’s, and review / approval / issuance of master documentation related to operational areas and evaluates compliance of all procedure (SOP’s) and master documentation with regulations and BMS Policies.
- Provides guidance and support on the transfer and introduction of new products and processes to the site to maintain quality and compliance. Coordinates Fact Findings documentation following Worldwide Quality and Compliance Directive and conducts root cause analysis to guarantee that underlying problems are identified and resolved.
- Support Field Alert Report/Biological License Application (FAR/BLA) and Recall investigations and provides tracking to any Site Planned deviation. 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.
- Provides support to the Senior Manager on monthly Quality Council meeting presentations. Develops impact assessments related to Policies and Directives implementation.
- Ensures corporate policies and directives are implemented in a timely fashion, following pre-establish schedule.
- Support the Inspection Readiness Program. Provides support to Site Projects. Provides compliance oversight and verifying compliance with BMS and WWQ&C Policies and Guidelines and site cGMP compliance policies and procedures are addressed.
- Provides compliance oversight and verifying compliance with BMS Policies, guidelines and regulations Liaison for regulatory initiatives Supports product submissions.
- Evaluates, follows up and approves Change controls for the Manati site, including interaction with corporate support areas, other BMS sites and third parties.
- Ensures Change controls are created according to local SOPs and corporate directives with all the appropriate requirements in placed for each change control. Supports actively the engineering, laboratories and Supply chain areas for Quality and Compliance documentation and site oversight providing coaching from Quality perspective.
- Provides guidance on gaps identified from the review and actively participates to determine potential remediation activities. Provides technical guidance and quality assurance support in the transfer of new products and process to maintain quality standards.
- Participates in Manufacturing Alignment Teams (MAT) and Project Alignment Teams (PAT), department staff, planning and change control board meetings as required.
- Maintains communication with internal and external customers to ensure compliance and timely completion of the assigned activities.
- Evaluates OP’s, BR’s, BOM’s, WPP’s, qualification and validation Protocols, according with government regulations and BMS Policies.
Qualifications & Experience
- Bachelor or Master Degree in Science (Degree or master in Chemical, Engineering, Biology or Microbiology).
- Five 5 years of experience in Quality Unit responsibilities in the pharmaceutical industry.
- Fully Bilingual (Spanish/English) communication skills, both written and verbal are required.
- Strong knowledge of relevant GMP, FDA, EU regulations.
- Expert in the interpretation and application of regulations according with the intended use.
- Self-motivated, creative and team work oriented.
- Excellent interpersonal skills and the ability to interact with people at all levels.
- Strong Technical Writing Skills to prepare trends analysis, investigation reports and regulatory and internal audits responses.
- Self-motivated, creative and teamwork oriented.
- Self-starter and good organizing and planning skills
- Excellent knowledge of computer systems (Microsoft Office, etc.) and tracking system like QCIS and Trackwise.
- Strong knowledge and experience in statistical tools
- Strong presentation skills
- Able to exercise good judgment
- Able to work under pressure
- Willing to work irregular hours, rotation shifts, weekends and holidays, when necessary.
- Sense of urgency and analytical thinking are some of the critical competencies required for this position.
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.
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.
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@example.com. 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.
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