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Replimune, Inc. Senior Director/Executive Director, R&D Quality Compliance in Woburn, Massachusetts

The Senior Director/Executive Director, R&D Quality Compliance, is responsible for owning and executing audit, inspection and quality risk management in GLP/GCP/GVP areas. The Senior Director/Executive Director, R&D Quality Compliance, will also make cross GxP impact by owning the Quality Governance related process and charters, overseeing Quality Risk Management and driving consistency and best practices in inspection management.

  • This position can be based either in our Woburn office or be a remote role

  • Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.

  • Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

Key responsibilities:

  • GLP/GCP/GVP Audits

  • Responsible for planning and executing an internal and external quality audit program, working closely with qualified audit vendors and with internal Qualified Quality personnel as applicable. Tracks audit corrective actions and remediations.

  • Employ risk based and data driven approach in audit planning. Ensure consistency in audit planning and execution, implementing best practices.

  • Ensure clear cross functional communication of audit plans, audit related metrics and trends. Ensure timely notification and escalation of high risk areas identified in audits.

  • Establish and maintain Qualified Vendor List and supporting audit strategy.

  • GLP/GCP/GVP Inspections

  • Manage the implementation, maintenance, and execution of Inspection Management. Direct maintenance of inspection opening presentation materials to ensure consistency and currency. Manage internal inspection logistics. Oversee the provision of inspection related training.

  • Responsible for developing, tracking, and reporting of inspection related metrics and communicating/escalating significant risks/trends.

  • Manage and host inspections with regulatory agencies (e.g. FDA, EMA etc.)

  • Review and approve Replimune responses to Regulatory Authorities’ inspections. Assesses proposed corrective or preventive actions in response to inspection findings. Track and report closure of commitments, and communicate/escalate areas of risk or concern.

  • Quality Governance and Quality Risk Management

  • Establish and continue to improve the Quality Governance process such as Quality Council and QMR. Establish and evolve the scorecards and risk registers to enable management oversight required.

  • Guide the organization on implementation of robust quality risk management program.

  • Provides leadership and partners with QA management team in proactive and strategic planning for QA and translation of the strategy to operating plans for execution. Drive effectiveness and efficiency of Quality Compliance processes through continuous improvement while keeping current with emerging and changing regulations, guidance documents and industry best practices and expectations.

  • Other duties as assigned.

Other responsibilities:

  • Recruit, hire, develop, and retain qualified staff who embrace culture and core values, and increase organizational performance.

  • Manages staff and consultants, and ensures the roles are performed effectively.

  • Ensures that all staff and consultants are appropriately trained on an ongoing basis and have complete training records.

Educational requirements:

  • A or B.S. degree in an appropriate scientific field.

  • S., Ph.D. or another post-graduate degree is encouraged.

Experience and skill requirement:

  • 12-15 years’ experience in a quality role in a regulated biotechnology or pharmaceutical industry environment, preferably leadership experiences in R&D Compliance for a life sciences organization supporting development programs

  • Proven track record and experience in managing regulatory inspections (FDA, EMA, MHRA, HPRA)

  • Strong analytical skills, and the ability to analyze and identify trends and root causes

  • Very strong risk management and audit skills to independently evaluate quality compliance risks and progression of remediation

  • Significant experience reviewing/providing feedback on audit work performed by others

  • Proven leadership in developing individuals and teams and managing staff to achieve goals through empowering teams.

  • Demonstrated strategic planning and execution skills with a willingness to do hands on work to design/evolve and /or implement quality strategies and operational planning and oversight in a risk based and fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business

  • Knowledge and demonstrated experience in application of risk-based quality principles in a biotechnology and pharmaceutical environment

  • Broad and deep global health regulatory agency knowledge and experience across with current knowledge of industry trends and best practices for efficiency, compliance, and effectiveness.

  • Excellent verbal and written communication skills with demonstrated ability to influence cross-functionally complemented with strong change management experience, adaptability, resourcefulness

  • Operational Excellence experience with proven ability to lead improvement projects is desired

  • This position can be based either in our Woburn office or be a remote role

  • Our Woburn location welcomes hybrid work! Local candidates are expected to be on-site 2 days per week.

  • Remote candidates (i.e., living beyond 65 miles of our Woburn HQ) must be open to 10-25% travel to our Woburn HQ, every 4-6 weeks or as business needs require.

Requisition ID: 2022-1235

External Company Name: Replimune, Inc.

External Company URL: replimune.com

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