GCP Quality Assurance Manager

Job Title: GCP Quality Assurance Consultant Job Description The GCP Quality Assurance Consultant will provide expert clinical quality oversight across a diverse clinical development pipeline, ensuring robust Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) compliance. This role supports clinical trials from study start-up through late-stage development and regulatory submissions, with a strong focus on inspection readiness, audit activities, and continuous improvement of quality systems. The consultant will work closely with Clinical Operations, Pharmacovigilance, Regulatory Affairs, and external vendors in a fast-paced biotech environment, influencing key decisions that impact global clinical programs. Responsibilities Lead quality oversight activities across clinical development programs to ensure compliance with internal procedures and global regulations. Perform internal, external, and vendor audits, including planning, execution, reporting, and follow-up of audit findings. Evaluate suppliers and CRO partners for GxP compliance through structured supplier audits and assessments. Support GCP-regulated studies from start-up through submission by conducting GCP audits and quality reviews. Provide quality oversight of clinical trial processes, study documentation, and quality records to maintain high compliance standards. Support GCP and GVP quality activities in collaboration with Clinical Operations and Pharmacovigilance teams. Collaborate with Safety/PV teams on GVP-related quality activities and oversight of safety processes and associated quality systems. Prepare teams, documentation, and systems for health authority inspections, including inspection readiness initiatives. Support inspection management activities involving FDA, EMA, and MHRA, including coordination and response to regulatory queries. Manage deviations, CAPAs, quality events, and root cause investigations, ensuring timely and effective resolution. Investigate quality issues, drive corrective and preventive actions, and ensure effective closure and documentation. Maintain compliance with global regulations and internal Quality Management System (QMS) requirements. Own and improve quality management processes, including risk assessments and continuous improvement initiatives. Support SOP development, process improvements, and risk management activities across global clinical trials. Partner cross-functionally with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and QA leadership to resolve quality issues. Contribute to continuous improvement initiatives that enhance inspection readiness, quality systems, and clinical compliance. Support activities related to oncology and immunotherapy clinical programs, including regulatory submissions and data quality oversight. Essential Skills Minimum of 5+ years of Clinical Quality Assurance (QA) experience. Strong hands-on experience with Good Clinical Practice (GCP) in biotech or pharmaceutical environments. Proven experience supporting clinical trials across different phases of development. Exposure to Pharmacovigilance and Good Pharmacovigilance Practice (GVP) quality activities. Demonstrated audit experience, including internal, external, and vendor audits. Experience with regulatory inspection readiness and health authority inspections. Direct experience interacting with FDA, EMA, and/or MHRA on inspection or compliance matters. Strong stakeholder management skills with the ability to collaborate effectively with cross-functional teams. Excellent communication skills, both written and verbal, for engaging global stakeholders. Bachelor's degree or equivalent experience in a relevant scientific or healthcare discipline. Proficiency in managing CAPAs, deviations, quality events, and root cause analysis within a QMS framework. Additional Skills & Qualifications Experience working in a fast-paced biotech setting, particularly in oncology and immunotherapy programs. Familiarity with global clinical trials and associated regulatory submission activities. Knowledge of Quality Management Systems (QMS) and risk management processes. Experience with inspection readiness planning and execution for global regulatory authorities. Comfort working with electronic quality and clinical systems such as Veeva or similar platforms. Ability to lead cross-functional quality initiatives and influence continuous improvement across clinical programs. Strong analytical and problem-solving skills, particularly in the context of CAPA and root cause analysis. Ability to work independently in a remote consulting capacity while maintaining strong collaboration with US and UK stakeholders. Work Environment This is a remote consulting position within a highly cross-functional and collaborative biotech environment. The role operates in a fast-paced setting with significant interaction with Clinical Operations, Pharmacovigilance, Regulatory Affairs, and QA leadership. There is a preference for candidates working on Eastern Standard Time to facilitate effective collaboration with UK-based teams and global stakeholders. The position involves supporting global clinical trials, oncology and immunotherapy programs, and regulatory submission activities. Travel may be required up to approximately 30% of the time to conduct audits, attend inspections, and participate in key quality oversight meetings. The work environment emphasizes transparency, high-impact contributions to quality systems and inspection readiness, and close partnership across international teams. Job Type & Location This is a Contract position based out of Conshohocken, PA. Pay and Benefits The pay range for this position is $60.00 - $80.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Aug 28, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.