South San Francisco, CA

Clinical Quality Assurance Contractor

Reports To: VP, Quality Assurance

Department: Quality

Location: SSF Office / Hybrid / Remote

Type/Hours: Part-Time, Contract position, up to 20 hours per week

 

ABOUT THE JOB

Reporting to the VP, Quality Assurance, the Clinical Quality Assurance Contractor will lead and oversee quality assurance activities related to clinical development programs to ensure compliance with applicable global regulations (FDA, EMA, ICH, GCP) and internal quality standards. This role provides strategic and operational QA leadership across clinical trials, vendors, and internal stakeholders, supporting the successful execution of clinical programs from early-phase through late-stage development.

This role will serve as a key quality partner to Clinical Operations, Regulatory Affairs, Pharmacovigilance, and external vendors, ensuring inspection readiness, data integrity, and continuous improvement of the Clinical Quality Management System (CQMS).

OUR CORE VALUES

The below core values drive all that we do here at Star.  We are looking for like-minded individuals that feel passionately about these same values to join our team.

  • Patients are our Center of Gravity: We partner with patients in unique ways, to uncover and address their unmet needs.
  • Propelled by Data, Guided by Intuition, Informed by Expertise: We boldly explore new diseases, novel biology, and smart ways of working with a sense of urgency.
  • Mission Ready Crew: With courage and agility, we opportunistically challenge conventional wisdom and foster an environment of respect and continuous growth.

RESPONSIBILITIES

Clinical Quality Oversight

  • Provide strategic QA leadership and oversight for all clinical development activities in compliance with ICH-GCP, FDA, EMA, and other global regulatory requirements.
  • Establish, maintain, and continuously improve the Clinical Quality Management System (CQMS).
  • Serve as the primary QA representative for clinical programs, providing guidance throughout the clinical trial lifecycle.

Audits & Inspections

  • Plan, conduct, and oversee GCP audits, including:
    • Investigator sites
    • CROs and vendors
    • Clinical systems and processes
  • Manage audit findings, CAPAs, and follow-up activities.
  • Lead inspection readiness activities and support regulatory inspections (FDA, EMA, MHRA, etc.), including hosting and response management.

Vendor & CRO Quality Management

  • Provide QA oversight of CROs, clinical vendors, and partners.
  • Review and approve vendor quality agreements, SOPs, and key deliverables.
  • Monitor vendor performance and ensure compliance with contractual and regulatory requirements.

SOPs, Training & Documentation

  • Oversee development, review, and approval of clinical SOPs, policies, and work instructions.
  • Ensure effective GCP training programs for internal teams and applicable vendors.
  • Ensure clinical documentation and TMF practices meet regulatory and inspection standards.

Risk Management & Continuous Improvement

  • Identify quality risks and implement proactive risk mitigation strategies.
  • Drive quality metrics, trend analysis, and continuous improvement initiatives.
  • Support clinical deviations, quality events, and root cause analyses.

Leadership & Collaboration

  • Build, mentor, and lead the Clinical QA team (as applicable).
  • Act as a trusted QA advisor to senior leadership and cross-functional teams.
  • Represent Clinical QA in governance meetings and quality forums.

 

EDUCATION, EXPERIENCE & QUALIFICATIONS

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field (required)
  • Advanced degree (MS, PharmD, PhD) preferred
  • 10+ years of experience in Clinical Quality Assurance, Clinical Operations, or related GxP roles within biotech, pharma, or CRO environments
  • 5+ years in a leadership or management role
  • Demonstrated experience supporting global clinical trials (Phase I–III preferred)
  • Hands-on experience leading GCP audits and regulatory inspections
  • Deep knowledge of ICH-GCP, FDA regulations (21 CFR), EMA guidelines, and global clinical regulatory standards
  • Strong understanding of clinical trial processes, TMF requirements, and vendor oversight
  • Proven ability to assess risk, manage complex quality issues, and implement CAPAs
  • Excellent communication, leadership, and stakeholder management skills
  • Ability to operate effectively in a fast-paced, evolving biotech environment
  • Experience in early-stage or high-growth biotech companies
  • Experience working with virtual or outsourced clinical models
  • Strong problem-solving mindset with a collaborative leadership style
  • Up to 10% domestic and international travel, as required

ABOUT STAR THERAPEUTICS

Star Therapeutics is a Phase 3 clinical stage biotechnology company that aims to discover and develop best-in-class antibody therapies to transform the lives of patients with serious diseases. Founded by former True North executives, Star has built a team with significant scientific, clinical, regulatory, and commercial experience that has a demonstrated track record of success and is backed by top-tier biotech investors.  We pride ourselves on our collective passion in bringing innovative therapies to the clinic and are committed to patients for whom no or limited treatment options exist.

Star is headquartered in South San Francisco, CA.  More information about Star can be found on our website at www.star-therapeutics.com.

We are an equal opportunity employer and value diversity at our company.  We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

We anticipate the hourly pay for the Clinical Quality Assurance Contractor position in our South San Francisco, CA office to range from $125 to $160 per hour and will depend on current market data and the candidate’s qualifications for the role, including education, experience and geographic location.  The compensation described above is subject to change and could be higher or lower than the range described based on several factors.

Qualified candidates should apply via our careers page at: https://star-therapeutics.com/our-careers/

NO PHONE CALLS or AGENCIES, please.

Note to External Recruiters: Submission of unsolicited resumes prior to an agreement set in place does not create any implied obligation.