Clinical Quality Compliance Auditor

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.

Job Title: GCP Sr. Auditor, Quality Assurance

Location: Paramus, NJ

Job Type: Contract

Work Type: Onsite

Shift: 9.00AM-5.00PM

Job Description:

Summary:

• The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance.

• This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Company s compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment.

• The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits.

• This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials.

• The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates.

• The ideal candidate will have extensive GCP experience.

• This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies.

• They are based in Northern New Jersey and require the candidate to be on-site.

• Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance

JOB REQUIREMENTS:

• 5+ years of pharmaceutical experience

• BS degree in scientific, health care or related discipline

• Intensive GCP and safety background

• Experience with both internal and external process and systems audits

• Strong knowledge of development policies, procedures and standards (SOPs, QMS)

• Ability to work with global clinical teams in developing objectives for audits of clinical studies

• 10% Traveling required

TASKS AND RESPOSIBILITIES:

• Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials.

• Plan and conduct audits of specific clinical processes based on risk.

• Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor.

• Develop audit reports and distribute them to appropriate stakeholders.

• Own and manage related clinical vendor non-conformances.

• Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.).

• Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors.

• Support the preparation, coordination, and participation of regulatory agency inspections.

• Participate in and support quality improvement projects.

TekWissen Group is an equal opportunity employer supporting workforce diversity.