Manager, GCP/GVP Quality and Compliance
Princeton, NJ
Full Time
Pharmacovigilance
Experienced
SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
The Manager, GCP and GVP Quality & Compliance is responsible for supporting and maintaining quality and compliance programs to ensure adherence to global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations, guidelines, and company standards. This role will partner cross-functionally with Clinical Operations, Drug Safety/Pharmacovigilance, Regulatory Affairs, and external vendors to ensure inspection readiness, regulatory compliance, and continuous improvement of quality systems.
Key Responsibilities
The Manager, GCP and GVP Quality & Compliance is responsible for supporting and maintaining quality and compliance programs to ensure adherence to global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations, guidelines, and company standards. This role will partner cross-functionally with Clinical Operations, Drug Safety/Pharmacovigilance, Regulatory Affairs, and external vendors to ensure inspection readiness, regulatory compliance, and continuous improvement of quality systems.
Key Responsibilities
- Ensure GCP/GVP activities are conducted in accordance with applicable global regulations (e.g., EMA, FDA, ICH).
- Contribute to the development, review and maintenance of clinical, pharmacovigilance and quality/compliance related SOPs.
- Plan, oversee and/or conduct GCP/GVP internal and external audits.
- Collaborate with cross-functional teams to investigate and manage GCP/GVP-related quality issues, deviations and CAPAs.
- Perform Quality Monitoring (QM) of safety reports to ensure completeness, accuracy and consistency.
- Ensure timely submission of safety reports to regulatory authorities.
- Monitor and report on GCP/GVP-related KPIs and quality metrics.
- Support training on GCP, GVP, and compliance topics to internal staff and relevant stakeholders.
- Provide quality and compliance guidance to project teams, clinical staff, and PV teams.
- Support development, implementation and management of inspection readiness strategies.
- Support sponsor and regulatory authority inspections.
- Collaborate with cross-functional teams to embed a quality mindset into day-to-day activities
- Contribute to continuous improvement initiatives to enhance quality culture and compliance maturity.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field required (advanced degree preferred).
- 5+ years of experience in Quality Assurance, Clinical Research, or Pharmacovigilance within the pharmaceutical/biotech industry.
- Strong working knowledge of global GCP/GVP regulations and requirements.
- Experience conducting or managing audits (clinical sites, CROs, vendors, PV systems).
- Prior involvement in health authority inspections preferred.
- Strong analytical, problem-solving, and organizational skills.
- Excellent written and verbal communication skills with ability to interact effectively at all levels.
- Ability to work independently and collaboratively in a fast-paced, dynamic environment.
- Proficiency in Microsoft Office Suite and electronic quality systems.
Compensation and Benefits:
The expected base salary range for this position is $90,000 - $130,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
The expected base salary range for this position is $90,000 - $130,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
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