PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 48 countries and more than 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
We have an exciting career opportunity within our Global Quality and Compliance department:
This role will primarily be in support of the GCP audit program but will include opportunities to participate in audits associated with the PV audit program.
The Major Responsibilities The Principal QA Auditor Will Include
- Conducting complex internal and external audits and inspections to ensure compliance with established quality assurance processes, standards, global regulatory guidelines and/or client contractual obligations.
- Identifying issues impacting the quality and/or integrity of clinical research programs, determines root cause of non-conformance and develops strategies to address issues.
- Performing technical document review and other GxP practice activities in support of clinical development programs.
- Providing audit reports to management.
- Serving in a lead capacity providing mentorship and guidance to junior auditors. Facilitates client audits or regulatory authority inspections.
Education And Experience
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, and experience.
Knowledge, Skills And Abilities
- Expertise in GxP and appropriate regional clinical research regulations and guidelines
- Excellent training/mentoring experience of junior auditors on a variety of co-audit types
- Solid experience with a wide range of GxP audits (e.g. routine, directed, vendor, internal, database, client audits, complex process and systems audits)
- Excellent oral and written communication skills
- Well developed problem solving, risk assessment and impact analysis abilities
- Extensive experience in root cause analysis
- Strong negotiation and conflict management skills
- Flexible and able to multi-task and prioritize competing demands/work load
- Valid driver's license and ability to qualify for and maintain a corporate credit card with sufficient credit line for business travel
- Provide initial training
- Ensure a working environment of high quality and standards
- Offer a competitive remuneration package
- Give you an opportunity for a challenging and rewarding career
In order to apply, please submit your CV in English. PPD is an equal opportunities employer.
Method of Application
Interested and qualified? Go to PPD career website on ppdi.referrals.selectminds.com to apply