Senior Director, GCP & GVP Quality
Scorpion Therapeutics, Somerville, ME, United States
The Role:
The Senior Director, GCP & GVP will lead clinical quality and pharmacovigilance strategy across development-stage programs. This role ensures global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) compliance, provides guidance on clinical trial operations and safety reporting, and fosters a culture of quality, compliance, and patient safety. The Senior Director drives proactive risk identification and mitigation across the clinical development and pharmacovigilance lifecycle, ensuring inspection readiness and effective regulatory engagement. This leader will partner cross-functionally to embed quality and safety considerations in clinical planning and will oversee a small, high‑performing team of quality and pharmacovigilance professionals. How you will contribute:
Lead GCP and GVP quality strategy and execution across clinical programs, ensuring compliance with FDA, EMA, and other global regulations. Maintain a phase‑appropriate Quality Management System (QMS) for clinical and pharmacovigilance activities, including SOPs, training, document control, and vendor oversight. Oversee clinical quality and pharmacovigilance activities: site/vendor audits, deviation management, CAPAs, and safety reporting compliance. Serve as the primary contact for internal teams and CROs/vendors on clinical quality and safety matters. Support EU clinical compliance and collaborate with the Qualified Person (QP) on European clinical supply certification and release. Drive inspection readiness and support regulatory inspections and submissions (IND, CTA, BLA, MAA). Develop and monitor key quality and safety metrics to identify risks, ensure patient safety, and support continuous improvement. Lead, mentor, and develop a small team of GCP/GVP professionals. Partner with Regulatory Affairs to align quality and safety with regulatory strategy. Leadership Responsibilities
Set high standards for performance and accountability, ensuring clarity of expectations and outcomes. Recruit, develop, and retain diverse, high‑performing team members. Foster transparent, courageous communication and cross‑functional collaboration. Encourage adaptability and calculated risk‑taking, modeling resilience through change. The Ideal Candidate will have:
BS or advanced degree in biology, chemistry, life sciences, or related field. 10+ years
in biotech/pharma, with
6+ years in clinical quality and pharmacovigilance leadership . Strong knowledge of GCP, GVP, and global regulatory expectations, including EU regulations. Experience supporting both early‑ and late‑stage development programs. Demonstrated success with inspection readiness and direct interactions with health authorities. Strong communication, collaboration, and leadership skills in a fast‑paced, high‑growth environment. Nice to Have
Prior experience with regulatory submissions. Proven ability to influence cross‑functional stakeholders in an outsourced model. Location:
This role will be based out of our headquarters in Somerville, MA. Open to hybrid work arrangement (in office 2-3 days/week) Compensation:
The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job‑related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range: $210,000 — $315,000 USD Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
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The Senior Director, GCP & GVP will lead clinical quality and pharmacovigilance strategy across development-stage programs. This role ensures global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) compliance, provides guidance on clinical trial operations and safety reporting, and fosters a culture of quality, compliance, and patient safety. The Senior Director drives proactive risk identification and mitigation across the clinical development and pharmacovigilance lifecycle, ensuring inspection readiness and effective regulatory engagement. This leader will partner cross-functionally to embed quality and safety considerations in clinical planning and will oversee a small, high‑performing team of quality and pharmacovigilance professionals. How you will contribute:
Lead GCP and GVP quality strategy and execution across clinical programs, ensuring compliance with FDA, EMA, and other global regulations. Maintain a phase‑appropriate Quality Management System (QMS) for clinical and pharmacovigilance activities, including SOPs, training, document control, and vendor oversight. Oversee clinical quality and pharmacovigilance activities: site/vendor audits, deviation management, CAPAs, and safety reporting compliance. Serve as the primary contact for internal teams and CROs/vendors on clinical quality and safety matters. Support EU clinical compliance and collaborate with the Qualified Person (QP) on European clinical supply certification and release. Drive inspection readiness and support regulatory inspections and submissions (IND, CTA, BLA, MAA). Develop and monitor key quality and safety metrics to identify risks, ensure patient safety, and support continuous improvement. Lead, mentor, and develop a small team of GCP/GVP professionals. Partner with Regulatory Affairs to align quality and safety with regulatory strategy. Leadership Responsibilities
Set high standards for performance and accountability, ensuring clarity of expectations and outcomes. Recruit, develop, and retain diverse, high‑performing team members. Foster transparent, courageous communication and cross‑functional collaboration. Encourage adaptability and calculated risk‑taking, modeling resilience through change. The Ideal Candidate will have:
BS or advanced degree in biology, chemistry, life sciences, or related field. 10+ years
in biotech/pharma, with
6+ years in clinical quality and pharmacovigilance leadership . Strong knowledge of GCP, GVP, and global regulatory expectations, including EU regulations. Experience supporting both early‑ and late‑stage development programs. Demonstrated success with inspection readiness and direct interactions with health authorities. Strong communication, collaboration, and leadership skills in a fast‑paced, high‑growth environment. Nice to Have
Prior experience with regulatory submissions. Proven ability to influence cross‑functional stakeholders in an outsourced model. Location:
This role will be based out of our headquarters in Somerville, MA. Open to hybrid work arrangement (in office 2-3 days/week) Compensation:
The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job‑related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package. Per Year Salary Range: $210,000 — $315,000 USD Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
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