Address: Paramus , NJ 07652
Telephone: 901-207-8038
Email Address: smithassociates1725@gmail.com
Hours: Office Hours 3:30 PM – 8:00 PM CST
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.
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Position Title: GCP Sr. Auditor
ATTENTION: ” $TOP PAY “(Interviewing Now)
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Location : Paramus, NJ
Salary : Competitive
– Experience level: Mid-senior
– Experience required: 5 Years
– Education level: Bachelor’s degree
– Job function: Accounting/Auditing
– Industry: Pharmaceuticals
– Total position: 1
– Relocation assistance: No
– Visa sponsorship eligibility: No
JOB DESCRIPTION:
– 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 have 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
RESPONSIBILITIES:
– Plan and conduct scheduled global clinical processes 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:
1. 5+ years of pharmaceutical experience
2. BS degree in scientific, health care or related discipline
3. Intensive GCP and safety background
4. Experience with both internal and external process and systems audits
5. Strong knowledge of development policies, procedures and standards
(SOPs, QMS)
6. Ability to work with global clinical teams in developing objectives for
audits of clinical studies
7. 10% Traveling required
For consideration you must act now, send resume to
smithassociates1725@gmail.com. Sincerely,
Gerald Smith
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