Manager, Compliance and Quality Systems

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The Manager, Compliance and Quality Systems maintains responsibility for all routine Compliance and Quality Systems activities at the Devens Biologics site. This includes the execution of annual product reviews, internal audits, regulatory observation and intelligence activities, and support of commercial and clinical change management and inspection management.

KNOWLEDGE AND SKILLS :

Required:

• A minimum of 8 or more years of relevant experience in a biologics or pharmaceutical manufacturing environment is required. Prior GMP compliance / Quality Systems experience is preferred.
• Knowledge of science or engineering generally attained through studies resulting in a Bachelor's degree in a scientific or technical discipline.
• Strong project management skills (organization, collaboration, multi-tasking and communication), high degree of attention to detail, and the ability to perform well in a team-based environment are required.
• Excellent computer skills and proficiency with MS Office is required. Advanced knowledge of Excel preferred.
• Basic understanding of manufacturing processes, drawings and specifications and quality systems, including knowledge of applicable U.S. and E.U. cGMP regulations/guidance pertaining to change control required.
• Candidate must be familiar with and able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMA, Health Canada, etc.
• Demonstrated ability to effectively establish proper priorities and to communicate complex information clearly and concisely, with demonstrated knowledge of subject matter related to quality and compliance.

Preferred

• Previous work experience with TrackWise/Veeva and responsibilities related to metrics and data analysis preferred.
• Experience in high-risk investigations and/or change controls is highly desirable

MAJOR RESPONSIBILITIES :

• Local process owner for one or more of the following at the Devens site: Annual Product Quality Review (APQR), Self-Inspections, Global Regulatory Evaluations (GROe), and Change Management; with responsibility to ensure site alignment with global policies and procedures.
• Maintains related site procedures and drives opportunities for continuous improvement in support of enhanced quality system performance.
• Manages program metrics process by developing applicable tools and trackers, generating and analyzing quality system data for trending, performance deficiencies, and conformance to KPIs. Develops appropriate action plans as needed to remediate or continually improve on quality system performance.
• Presents related metrics to site Quality and operations management.
• Leads completion of APQR reports including project management, compilation of report sections, and driving review/approval by established timelines.
• Supports the Devens self-inspection program as a lead auditor. Develops, plans, and conducts audits, writes audit reports, reviews finding response, and tracks corrective actions and audit closures.
• Provides support to the site Quality Management to ensure site compliance with applicable regulatory, cGMP and BMS requirements.
• Reviews and assesses more complex policy/procedure revisions, network regulatory observations, and compendia updates against site processes, procedures and methods.
• Leads remediation plans for major impact or complex observations.
• Ensures all commitments are tracked for timely completion.
• Manages Devens change control system as site SME and representative on global changes (manages impact assessor assignments, ensures compliance to established procedures, facilitates movement of records through the process).
• Facilitates Local Change Review Board (LCRB), assures consistent, effective use of the site change control system for all change requests.
• Ensures supporting documentation and change deliverables meet external regulatory and internal Global BMS guidelines and requirements.
• Provides compliance and quality support to site Quality Risk Assessments through participation in formal risk assessments and review and approval of reports, as delegate of Quality Risk Management (QRM) LPO.
• Supports the Site Inspection Readiness Program by conducting prep sessions with SMEs and mock inspections.
• Core inspection team member. Executes targeted inspection preparation activities. Leads SME preparation room / back room during inspections or supports front room activities.
• Generates Quality System queries and reports as needed during inspections.
• Conducts user training on internal audits and inspection readiness as needed.

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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.

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