Senior Manager, Compliance and Quality Systems

Principal objective of the position:

To maintain Internal Compliance activities at the Devens site. This includes program ownership of site compliance with BMS corporate policies and procedures as well as management of pre- and post-filing Health Authority requests. The Internal Compliance Manager will have the role of Local Process Owner for Audits & Inspections and Data Integrity quality processes.

Responsibilities:

• Local process owner for Audits & Inspections at Devens site with responsibility to ensure site alignment with global policies and procedures.
• Local process owner for Data Integrity at Devens site with responsibility to ensure site alignment with global policies and procedures.
• Key point of contact with Global Regulatory Services to respond to pre- and post-filing requests for site based information, includes extensive communication and coordination to fill a variety of requests.
• Responsible for Site Self-Inspection Program. May conduct audits of site functions relative to BMS policies and procedures as well as the relevant HA requirements.
• Provides compliance expertise and guidance to the site on applicable regulatory, cGMP and corporate requirements; supporting local projects as the Compliance & Quality Systems representative as needed (researching as needed on complex compliance issues).
• Participates as a core team member in any corporate or health authority inspections and leads cross functional teams to develop responses, tracking the commitments to completion.
• Leads site inspection readiness efforts with regard to preparing site for health authority inspections and corporate audits.
• Leads site response for Global Regulatory Observation Evaluations (GROe).
• Leads/participates in data integrity assessments and remediation efforts and provides Compliance oversight and Quality review of data integrity assessments and remediation activities.
• Represents site as the Quality representative on network compliance initiatives and providing compliance leadership, guidance and problem solving skills.
• Participates in site Quality Council and provides metrics reporting as needed.

Knowledge and Skill:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
• A minimum of 10 years of relevant experience including 4 years of GMP Quality experience.
• Proven experience in Health Authority inspection preparation and management (backroom and front room) is required.
• Candidate must be familiar with and be able to interpret relevant regulations, regulatory agency inspection expectations e.g. FDA, EMEA, Health Canada, etc.
• Background in Quality Systems in commercial biologics in an FDA regulated environment (i.e. investigations, change control, internal/external auditing, documentation, training, quality control labs, or bulk manufacturing).
• Demonstrated knowledge of at least one enterprise computer-related system used for recording of Quality System data (e.g. Trackwise, Veeva, SAP, LIMS, Documentum)
• Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.

Working Conditions:

• Work is largely performed in an office environment. During audits, there is the potential for exposure in the laboratory and manufacturing facility where one must be aware of the presence of workplace standards including pressurized liquids gases, steam and hazardous chemicals. Use of Personal Protective Equipment (PPE) will be required in some portions of the facility during an internal audit or HA inspection.

Decision Making:

• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Makes sound decisions and applies appropriate notification to management as appropriate.
• Establishes operational objectives in alignment with direct manager and delegates assignments to subordinates.
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
• Capable of independently leading key cross-functional strategic initiatives for site and BMS.
• Able to identify and escalate significant issues to senior management with recommendation for corrective actions.

Supervision Received:

• Works with minimal supervision on the accomplishment of agreed upon goals and objectives.
• Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.