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Position Summary

BMS Cruiserath Biologics is seeking to recruit a permanent Senior Manager, QA Compliance who is responsible for oversight and implementation of the regulatory compliance elements of the Quality Management System, the Supplier Quality Management program, inspection readiness program and the Data Integrity program at Cruiserath Biologics. This position is responsible for the recruitment, development, and management of the QA Compliance team and is reporting to the Associate Director, Quality Systems and Compliance.

Key Duties and Responsibilities:

• Responsible for the internal audit/self-inspection program at the site - including management of procedures, development of annual schedule, execution of audits and management of response development and remediation.  Tracking commitments to completion, identifying trends, and escalating accordingly.

• Leads the Site Inspection Readiness Program by liaising with site SMEs, conducting mock inspections as required and tracking completion of all site inspection readiness tasks.

• Leads the site Data Integrity program.

• Provides compliance expertise and guidance to the site on applicable regulatory, cGMP and corporate requirements.

• Responsible for maintenance of the inspection logistics program including administration of ACE system. 

• Participates as a core team member in any corporate or regulatory agency inspections and supports cross functional teams to develop responses, tracks the commitments to completion.

• Point of contact for License Management.

• Responsible for the provision of general regulatory compliance support to applicable markets pertaining to regulatory/ filing submissions.

• Participates in the product recall and health authority notification process in accordance with BMS procedures.

• Responsible for the Site Master File, Supply Chain Flow Maps, and the associated procedures.

• Manages the internal compliance program at the site - including review of site procedures relative to BMS corporate policies and directives. Documents impact assessments and track commitments to completion. Escalates site compliance issues accordingly.

• Manages Quality oversight of Supplier Quality Management and external audit program as required including reviewing, approving, and tracking corrective actions related to external audits.

• Manages the Supplier Quality Agreements program to ensure that raw material suppliers, service suppliers and equipment vendors meet applicable regulatory and company requirements.

• Responsible for the supplier non-conformance investigation program and escalation of critical events to senior leadership.

• Serves as a Subject Matter Expert SME for internal audits/self-inspection, supplier management, Site Master File, and general site GMP compliance.

• Supports the site Quality Management Systems program.

Qualifications, Knowledge and Skills Required:

• A degree in a science, engineering or related discipline is essential along with minimum of 10 years’ experience in the biopharmaceutical industry, preferably in Quality, Manufacturing Technology, or Regulatory areas, or a position within a Health Authority Agency.

• Experience of Leadership and management skills.

• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written

• Strong technical background in biologics.

• Understanding of GMP Principles pertaining to Biologics manufacture.

• Demonstrates expert knowledge of EU, FDA, ICH and BMS Corporate cGMP policies and guidelines.

• Understanding of manufacturing unit operations

• Understanding of Internal Regulatory requirements

• Planning and organizing skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities and a dynamic work environment.

Why you should apply

• You will help patients in their fight against serious diseases

• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees

• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical assurance, 27 day annual leave, life assurance and on-site gym

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.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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