Director, Quality Assurance, GCP

Xenon Pharmaceuticals•Needham, MA

7d•$216,400 - $234,900•Hybrid

About The Position

We are seeking a Director, Quality Assurance, GCP/GLP to join our team. We are building our Quality function to support Xenon’s clinical development programs, as well as expand quality initiatives across the company. This person will provide Quality leadership primarily in support of early-stage clinical programs (pre-phase 3) and non-clinical studies. This position will contribute to inspection readiness initiatives and for ensuring compliance within R&D Program. The successful candidate must have a strong clinical/non-clinical quality background, including providing Quality support for study teams, auditing, and inspections. This position must have exceptional interpersonal skills, excellent communication skills, and a collaborative and pragmatic approach to Quality. This position reports to the Executive Director, Quality Assurance, GCP and will be based out of Boston, MA, USA in our Needham office. We will consider remote locations 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.

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

Lead and manage quality oversight of the Company’s GLP programs, including the GLP audit program, collaborating with Quality Systems to develop an annual GLP audit plan.
Lead and manage quality oversight of the Company’s early phase clinical programs.
Provide expert GLP/GCP compliance interpretation, consultation, training, root cause analysis, and other supportive services necessary to maintain and improve the quality of the Company’s R&D programs to safeguard study participants’ safety and rights and ensure the quality, integrity, and credibility of data generated.
Identify and escalate critical quality issues appropriately to QA Management.
Assist with the preparation and coordination of regulatory inspections held remotely and onsite at the Company’s offices, clinical trial sites, and contract service provider facilities, as needed.
Maintain respectful, inclusive, and effective cross-functional communications, collaborating with internal and external stakeholders on strategy and implementation of quality principles and regulatory requirements while remaining independent.
Ensure compliance with relevant legislation and regulations.
Develop and propose short- and long-term objectives for the GLP/GCP functions in accordance with overall Company and Quality strategies.
Plan and manage budget proposals and approved budgets in accordance with the Company’s strategic and operating plans and Finance policies.
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
Other duties as assigned