Compliance Specialist II, Cell Therapy Manufacturing (R1558557-en-us)
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.
PURPOSE AND SCOPE OF POSITION:
BMS Cell Therapy Manufacturing seeks Compliance Specialists within Manufacturing that bring enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs. The candidate must be goal-oriented, flexible, and able to work collaboratively with safety and quality in mind. We are searching for enthusiastic, innovative individuals with a good understanding of good manufacturing practices to support and maintain several elements within the Quality Systems framework to ensure site compliance with GxPs and BMS policies.
DUTIES AND RESPONSIBILITIES:
- Supports readiness of the facility for Regulatory Inspections
- Identifies, manages, and owns Corrective Actions and Preventive Actions (CAPA)
- Supports internal / external audits following the annual site plan with respective reports and action items from areas impacted during the audit
- Prepares, submits, and discusses reports of assigned Quality Systems status for trending and evaluation to the site management
- Aligns facility Quality Systems with GMPs, Regulatory Standards and domestic requirements
- Generates, reviews, and implements departmental procedures and forms to assure compliance with current practices, GMPs, and/or trends
- Supports the Quality Risk Management program at the site participating in multidisciplinary teams
- Develops impact assessments related to Policies and Directives implementation
- Ensures the site has an internal audit program and that all system audits are conducted at a specified frequency
- Evaluate functional strengths and developmental areas a team with the ability to focused on continuous improvement as it relates to compliance
- Responsible for reviewing qualification and re-qualification of manufacturing related equipment and facility as the operations representative
- Develop internal controls and policies to ensure that all compliance needs are met
- Work closely with department SMEs to review all departmental policies for compliance alignment
- Work as a liaison between Manufacturing and Quality Operations and relevant Management systems
- Serve as a resource for Tech Transfer activities
- Lead and train manufacturing teams to review manufacturing batch records, testing data, SOPs, Deviations, Change Controls, and Corrective and Preventative Action (CAPA).
- Communicates Quality related initiatives and actions to all functional area managers
- Must have the ability to challenge and make recommendations
- Escalate compliance concerns to management in a timely manner
- The ability to review and approve change controls as the manufacturing compliance representative
- The ability to work as the functional area approver and reviewer · Maintain CAPA databases and Investigations and prepare trend reports
- Ensure high levels of communication with team, support resources and management regarding issue identification and resolution
- Other duties as assigned
Education and Experience:
- Bachelor’s degree required
- 5+ years hands on experience in biotechnology/pharmaceutical manufacturing practices, guidelines, cGMP knowledge, and production operations
- 5+ years in a Manufacturing/Operations in a cGMP environment is required
- An equivalent combination of education, experience, and training may substitute.
- Cell Therapy manufacturing experience preferred.
- Prior experience in a quality role preferred.
Knowledge, Skills, and Abilities:
- Ability to work by influencing peers and gain their cooperation; working collaboratively
- Incumbents act with very limited supervision for routine activities to determine methods and procedures on new assignments
- A high sense of urgency and a commitment to delivering results is essential.
- Advanced time management skills, including ability to prioritize and manage expectations
- Advanced proficiency in Microsoft Office
- Advanced technical writing skills
- Advanced knowledge of GMP manufacturing and regulations
- Intermediate knowledge of qualification and validation requirements in a regulated environment
- Basic presentation development and delivery skills
- Ability to provide accurate estimates and effectively communicate status of deliverables
- Ability to gown into Grade C and D classified environments
- Must be familiar with many GMP-related aspects and systems like:
- Quality Risk Management
- Document and Data Governance
- Monitoring and Quality Reports
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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