Senior Compliance Manager Supplier Quality Management Cell Therapy

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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:

The Supplier Quality Management (SQM) Compliance Manager will manage and coordinate the oversight and execution of the following Quality Systems within Cell Therapy Development & Operations (CTDO)Supplier Quality: Trend and Management Review, Annual Product Review, GMP Training, and Quality Risk Management. In addition, the SQM Compliance Manager will perform routine monitoring of eQRMS to ensure that quality records owned/assigned to SQM are completed on time and per procedure. The Compliance Manager will ensure operational compliance with the associated SOPs of the global quality system in order to provide and maintain control of cGMP operations within SQM.

Required Competencies: Knowledge, Skills, and Abilities


Advanced knowledge of current Quality and Good Manufacturing Practices.
Ability to critically assess project(s) and facilitate resources to efficiently achieve goals, implement solutions independently, and assist in development of employees.
Ability to lead and influence other team members.
Ability to prioritize tasks based on guidance from manager and based on current business demands
Advanced written and verbal communication skills. Provides guidance to others in technical writing and in interpretation of complex data.
Intermediate knowledge of risk management and the ability to apply the concepts of risk management effectively.
Advanced knowledge of quality management standards and industry guidance on quality systems.
Ability to work effectively in teams.


Duties and Responsibilities


Manage and Coordinate SQM Trend and Management Review
Coordinate collection of metrics from the team in the prescribed format
Schedule and facilitate meetings
Conduct follow-up with team SMEs as applicable
Collate required reports
Provide inputs to Global Management Review process (eg liaison to Global Quality Systems)
Manage and Coordinate Annual Product Quality Review (APQR)
Prepares communications and meetings
Facilitates collection of information from team SMEs.
Prepares and submits reports to GPQ by required deadlines.
Conduct follow-up with area SMEs
Manages SQM GMP Training Program
Ensures that training curriculum are in place for each job role
Identifies and maintains the requirements for core SQM training
Provide Department Metrix
Coordinate and prepare global requirements related to compliance
Emerging Regulations
Global Trend Review
FDA Metrics
Monitors eQRMS Quality Records for SQM
Lead the development, execution and maintenance of the Supplier Events Investigation Program (SEIP)
Develop expertise in eQRMS reporting to enable easy report generation in support of APR and/or QMR
Provide routine monitoring of quality records assigned to SQM staff. Provides timely reporting of coming due and overdue assignments to the team. Provides KPIs to monitor SQM performance for on time closure.
Develop understanding of the roles required in eQRMS system to enable SQM staff to seamlessly perform their tasks
Owns Supplier Quality work practices for eQRMS
Owns and maintains a master dashboard for all CSPs and Material Suppliers in CTDO
Maintain a master dashboard identifying overall status of quality agreements, when periodic review is due, and overall status with supplier
SPOC to each CTDO site for inquiries related to Quality Agreement status and next audit due date
Establish metadata requirements for CTDO Quality Agreements. Work with team to define and implement CTDO specific templates for Quality Agreements
Maintain the audit data in the master tracking list. Track when audits are complete and when they are coming due. Ensure Audit team is scheduling audits on time.
Monitor the Audit/CAPA commitment tracking tool - ensure VQMs are following up with suppliers on open audit and CAPA commitments.
Owns associated SQM procedures.
Performs all other tasks as assigned


Education and Experience


Bachelor's Degree required.
10 years' of related Project Leadership experience in the Pharmaceutical Industry, with at least 5 of those years within Quality Assurance, is required.
Biologics or Cell Therapy Experience Preferred
Excellent knowledge of US cGMPs, cGLPs and/or cGCPs regulations required
Process Improvement Mindset is required.
Strong interpersonal, negotiation, influencing, and problem-solving skills are required.
Some supervisory experience is preferred.

30% travel may be required if working remotely.

An equivalent combination of education, experience and training may substitute.


Location

Position can be based in Summit, NJ, Seattle, WA, or Remote

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.

Company: Bristol-Myers Squibb

Req Number: R1527400_EN

Updated: 2020-07-10 00:00:00.000 UTC

Location: Summit,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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