Senior Manager, GCP Quality Assurance
Senior Manager, GCP Quality Assurance
Location: Greater New Jersey Area | Hybrid
A growing biopharmaceutical organization is seeking a Senior Manager, GCP Quality Assurance to support global clinical development programs. This individual will play a key role in ensuring clinical research activities are conducted in compliance with applicable regulations, industry standards, and quality expectations.
Key Responsibilities
- Partner with clinical development teams to provide GCP quality and compliance support across clinical programs.
- Support quality oversight activities for CROs, vendors, and external partners.
- Identify compliance risks and collaborate with stakeholders to implement appropriate mitigation strategies.
- Participate in audit activities, including vendor, site, and process audits.
- Assist with inspection readiness efforts and the management of quality findings and corrective actions.
- Provide guidance on GCP regulations, industry expectations, and quality best practices.
- Contribute to the ongoing improvement of quality systems, processes, and compliance programs.
Qualifications
- Bachelor's degree in Life Sciences or a related scientific discipline.
- 5+ years of experience within GCP Quality Assurance, Clinical Quality, or Clinical Compliance.
- Working knowledge of global GCP regulations and industry standards.
- Experience supporting audits, inspections, and quality oversight activities within clinical development.
- Strong communication, collaboration, and problem-solving skills.
- Ability to work effectively in a cross-functional and fast-paced environment.
Preferred Experience
- Background supporting clinical trials within the pharmaceutical, biotechnology, or life sciences industry.
- Experience partnering with external vendors and contract research organizations (CROs).
- Familiarity with risk-based quality management and clinical quality systems.
This is an excellent opportunity to join a growing organization and have a meaningful impact on the quality and compliance of innovative clinical development programs.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.