Clinical Quality and Compliance Manager
King of Prussia, PA
Our client is looking for an experienced Quality and Compliance Manager for a 12-month project with the potential for extension. If you are an experienced Quality and Compliance Manager, this position could be the next great step in your career. You must have extensive understanding of the clinical research and drug development lifecycle.
- Provide compliance support, including quality and compliance advice and consultation, to assigned study programs including maintenance of risk-based Compliance Plans
- Manage Inspection Readiness activities for assigned programs and collaborate with Clinical QA to prepare internal and external staff
- Support Clinical QA during the regulatory inspection process to provide expertise regarding the Clinical Development quality management system
- Oversee and assist in the quality control (QC) consistency checks of critical clinical documents to ensure compliance with ICH-GCP, internal policies/procedures, templates and formats required for regulatory filing and optimal clinical trial delivery
- Manage individual Corrective and Preventative Actions (CAPAs) including a risk assessment, root cause analysis and effectiveness measures) and identified actions are addressed
- Support the CQCC Lead in reporting metrics, identifying trends, and evaluating the effectiveness of completed CAPAs to drive continuous improvement.
- At least 5-7 years of professional work experience in a Clinical Development or Clinical Research environment
- Management experience is desirable
- Thorough knowledge of ICH GCP, FDA GCP Regulations and EU clinical trials directives
- Extensive experience of working in a global pharmaceutical environment
- Experience of working in a Quality related and/or Process Management related environment /role
- Strategic development and analytical skills
- A minimum of a Bachelor’s Degree (BSc/MSc/Diploma) in a scientific, medical or pharmaceutical discipline is essential
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.