Associate Director/Director, Quality Assurance, GCP

Xenon Pharmaceuticals • Needham, MA

14d • Hybrid

About The Position

We are seeking an Associate Director/Director, Quality Assurance, GCP to join our team. We are building the GCP Quality function to support Xenon’s clinical development programs, as well as expand quality initiatives across the company. This position will contribute to inspection readiness initiatives and for ensuring compliance within R&D Programs.
This position reports to the Executive Director, Quality Assurance, GCP and will be in Boston, MA, USA. We will consider other jurisdictions for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid positions require a minimum of two onsite days per week. On-site positions require up to five on-site days per week.

Requirements

• Bachelor’s degree in a scientific or health field with at least 10 years of GxP QA experience, 8+ years GCP QA, supporting both development and commercial programs in the pharmaceutical or biotechnology industry.
• A minimum of 5 years’ management level experience in a pharma or biotech environment. Job level commensurate with years of experience.
• Contemporary knowledge of GLP/GCP/GVP regulations, guidelines, current industry trends, standards, and methodologies.
• Sound understanding of all phases of the drug development process and the interdependencies with other functional areas.
• Experience in conducting audits, adapting issues into effective CAPAs, and evaluating trends to mitigate risks.
• Ability to prioritize work effectively to manage several complex projects in parallel, and successfully achieve critical milestones and expected deliverables within established timelines and budgets.
• Must be able to demonstrate strategic thinking, excellent organizational skills and be able to drive project teams forward while having willingness to do hands on work to achieve goals.
• Demonstrated ability to interact professionally and communicate clearly, concisely, and consistently both verbally and in writing with internal and external stakeholders.
• Proven ability to work independently and collaboratively as part of a multidisciplinary team.
• Proficient people management skills including mentorship, negotiation, and conflict resolution.

Nice To Haves

• Experience interacting with regulatory inspectorates (e.g., FDA, Health Canada, EMA, MHRA) is desirable.

Responsibilities

• Ensure the Company’s quality systems and activities are actively managed to include, but not limited to quality risk management, inspection readiness, quality issue management, data quality auditing, and GLP/GCP training.
• Manage internal and external GLP/GCP audit programs and activities, collaborating with key stakeholders to ensure quality compliance for current and future programs.
• Provide GLP/GCP compliance interpretation, consultation, training, and other supportive services necessary to maintain and improve the quality of the Company’s R&D programs to ensure the protection of study participants’ safety and rights and the quality, integrity, and credibility of data generated.
• Identify and escalate critical quality issues appropriately to QA Management; support investigations as required.
• Collaborate with internal departments to implement quality principles and regulatory requirements while remaining independent.
• Lead and manage GLP/GCP inspection readiness activities in preparation for pre-approval inspections.
• May contribute to GVP activities, as required.
• Participate in regulatory inspections held at the Company’s offices, clinical study sites, and contract service provider facilities, as needed.
• Recruit, lead, direct, develop, coach and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
• Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
• Some international travel may be required.
• Other duties as assigned.

Benefits

• Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
• Xenon encourages time to rest and re-charge through vacation, personal days, sick days, and an end-of-year company shutdown.
• Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

What This Job Offers

• Job Type: Full-time
• Career Level: Director