Executive Director, R&D Quality

Overview

The Executive Director, R&D Quality leads and sets strategy for R&D Quality team that provides GCP, GLP, GVP quality oversight in Replimune, driving value through a risk-based, proactive & preventative approach to quality. Acting as trusted Quality partner, this role leads the R&D Quality team and works closely with R&D functions in applying expert GCP, GLP and GVP knowledge and a risk-based approach, contributing to the advancement of R&D in Replimune. Importantly, this role needs to work cross functionally across the organization, influencing senior leaders and other stakeholders to effectively advance a culture of Quality across Replimune.

Responsibilities

• Responsible for R&D Quality strategy and execution, including quality elements covering Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) and Good Pharmacovigilance Practice (GVP).

• Partners cross functionally to enable transparency & escalation of R&D quality risks and issues, collaborating to address challenges and constraints. Establish strong partnership with senior leaders and key stakeholders, fostering a commitment to quality and a culture of quality

• Provide risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks

• Lead the analysis and interpretation of key quality data for the presentation and reporting to functional and executive leadership

• Lead and supervise the management of critical and/or complex quality including but not limited to the assessment of serious breaches

• Lead/oversee management of internal inspection readiness activities throughout program life cycle for study teams

• Will host GCP and GVP regulatory inspections, manage appropriate observation responses, and ensure timely implementation of all CAPA related activities

• Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations

• Lead and direct assessment of R&D risk areas and provide these insights to the Quality Audit and Inspection programs in order to prioritize oversight activities and propose modifications where necessary

• Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners

• Chairs select Quality governance meetings and quality forums, and drives an aligned escalation of QMS health to senior management and governance meetings

• Interface with key external Quality organizations for development vendors and partners

• Build strong R&D Quality team. Manage and develop staff to achieve goals through empowering team members.

• Supports overall QA goals and objectives. 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 processes through continuous improvement while keeping current with emerging and changing regulations, guidance documents and industry best practices and expectations.

• Leads intra or interdepartmental teams such as continuous improvement initiatives

• 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.

Qualifications

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 for a life sciences organization supporting development programs

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

• Experience in implementing principles for Quality Risk Management

• Demonstrated experience at building a team and developing strong QA team members

• Demonstrated ability to influence cross-functionally across the organization, including senior leadership, complemented with strong change management experience, adaptability, and resourcefulness.

• Strong analytical skills and risk management skills as well as collaboration acumen to lead investigations of complex R&D quality issues, identify CAPAs, evaluate quality risks and drive the progression of remediation.

• Demonstrated strategic planning and execution skills, and with a willingness to do hands on work to design/evolve and implement R&D quality oversight in a risk based manner enabling effectiveness, flexibility and adaptability.

• Broad and deep global health regulatory agency knowledge and experience across with current knowledge of industry trends and best practices

• Proven effective verbal and written communication skills including delivering presentations to functional and executive leaders.

• Excellent organizational management skills. Able to lead and mentor effective cross functional team.

Replimune is an equal opportunity employer.Replimune now requires COVID vaccination disclosure for all US employees.