GCP Sr. Auditor

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

RESPONSIBILITIES:

• 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.

QUALIFICATIONS:

• 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

Must have:

• Bachelor’s degree in a scientific, health care, or related discipline.
• Minimum 5 years of experience in the pharmaceutical industry
• The ideal candidate will have extensive GCP experience.
• Proven experience conducting and managing internal and external GXP audits, including clinical development and safety/pharmacovigilance audits.
• GCP guidelines and global regulatory requirements (e.g., FDA, EMA, ICH GCP).
• auditing CROs, CMOs, investigator sites, and clinical vendors.
• clinical systems such as IRT and EDC from an audit perspective.
• Familiarity with Quality Management Systems (QMS), SOPs, and compliance documentation.

Nice to have:

• Prior experience in a biopharmaceutical company focused on neurology or psychiatry therapies.

Additional information:

• Willingness and ability to work on-site in Paramus, NJ, three days per week (Tuesday, Wednesday, Thursday), with the possibility of change later (either more or fewer days), so candidates needed to be flexible.
• Availability for up to 10% travel.
• Excellent communication, reporting, and stakeholder management skills.