<html><body><h2 data-section-id="1wct3r9" data-start="153" data-end="170">About the Role</h2>
<p data-start="172" data-end="535">We are seeking an Associate Director/Director, Quality Assurance, GCP to join our team. This role will support the development of the GCP Quality function across clinical development programs, as well as expand quality initiatives across the organization. The position will contribute to inspection readiness initiatives and ensure compliance within R&D programs.</p>
<p data-start="537" data-end="935">This position reports to a senior Quality Assurance leader and is based in the United States (Boston, MA preferred). Other locations may be considered for exceptional candidates. The level of the position will be commensurate with the candidate’s education and industry experience. Hybrid roles require a minimum of two onsite days per week, while onsite roles may require up to five days per week.</p>
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<h2 data-section-id="r8dte7" data-start="942" data-end="961">Responsibilities</h2>
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<li data-section-id="111cogd" data-start="963" data-end="1164">Ensure quality systems and activities are actively managed, including but not limited to quality risk management, inspection readiness, issue management, data quality auditing, and GLP/GCP training</li>
<li data-section-id="17f1aa0" data-start="1165" data-end="1325">Manage internal and external GLP/GCP audit programs and activities, collaborating with key stakeholders to ensure compliance for current and future programs</li>
<li data-section-id="1auu0nn" data-start="1326" data-end="1500">Provide GLP/GCP compliance interpretation, consultation, training, and support to maintain and improve R&D program quality, ensuring participant safety and data integrity</li>
<li data-section-id="cgxrxp" data-start="1501" data-end="1600">Identify and escalate critical quality issues appropriately; support investigations as required</li>
<li data-section-id="1ab5ga1" data-start="1601" data-end="1733">Collaborate with internal departments to implement quality principles and regulatory requirements while maintaining independence</li>
<li data-section-id="1xxci1o" data-start="1734" data-end="1845">Lead and manage GLP/GCP inspection readiness activities, including preparation for pre-approval inspections</li>
<li data-section-id="abzm44" data-start="1846" data-end="1882">Support GVP activities as needed</li>
<li data-section-id="14hox20" data-start="1883" data-end="1996">Participate in regulatory inspections at corporate offices, clinical sites, and third-party service providers</li>
<li data-section-id="11bgn53" data-start="1997" data-end="2065">Recruit, lead, develop, and evaluate team members, if applicable</li>
<li data-section-id="x8yuxc" data-start="2066" data-end="2151">Ensure adherence to organizational policies, including code of conduct and ethics</li>
<li data-section-id="b1uycm" data-start="2152" data-end="2203">Support additional responsibilities as assigned</li>
<li data-section-id="wdbeat" data-start="2204" data-end="2249">Some international travel may be required</li>
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<h2 data-section-id="1fm6vrb" data-start="2256" data-end="2273">Qualifications</h2>
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<li data-section-id="vxmewe" data-start="2275" data-end="2336">Bachelor’s degree in a scientific or health-related field</li>
<li data-section-id="1pfudt2" data-start="2337" data-end="2468">10+ years of GxP Quality Assurance experience, including 8+ years in GCP QA within pharmaceutical or biotechnology environments</li>
<li data-section-id="1mik5j6" data-start="2469" data-end="2545">At least 5 years of management experience; level aligned with experience</li>
<li data-section-id="1tmw8hk" data-start="2546" data-end="2633">Strong knowledge of GLP/GCP/GVP regulations, industry standards, and best practices</li>
<li data-section-id="se6mu1" data-start="2634" data-end="2718">Experience interacting with regulatory agencies (e.g., FDA, EMA, MHRA) preferred</li>
<li data-section-id="hkp0ho" data-start="2719" data-end="2809">Understanding of all phases of drug development and cross-functional interdependencies</li>
<li data-section-id="1ckpvk0" data-start="2810" data-end="2896">Experience conducting audits, developing CAPAs, and performing risk/trend analysis</li>
<li data-section-id="dsfo3l" data-start="2897" data-end="2975">Ability to manage multiple complex projects and meet timelines and budgets</li>
<li data-section-id="g6rdbp" data-start="2976" data-end="3099">Demonstrated strategic thinking, strong organizational skills, and ability to lead initiatives while remaining hands-on</li>
<li data-section-id="kma465" data-start="3100" data-end="3195">Excellent communication skills (written and verbal) with internal and external stakeholders</li>
<li data-section-id="v9l00v" data-start="3196" data-end="3284">Ability to work independently and collaboratively in a multidisciplinary environment</li>
<li data-section-id="16vzwht" data-start="3285" data-end="3380">Strong people management skills, including mentorship, negotiation, and conflict resolution</li>
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