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.