Senior Manager, Quality Assurance GCP
Company: Otsuka Pharmaceutical
Location: Princeton
Posted on: June 26, 2022
Job Description:
Job Summary The incumbent is responsible for planning and
conducting GxP audits (i.e. clinical vendors, investigator sites,
quality systems, etc.) in addition to supporting clinical
manufacturing operations. The Quality Assurance team supports
Avanir throughout the product development and commercial life cycle
by providing appropriate knowledge/expertise/input, by
communicating effectively internally and with external stakeholders
and by ensuring that Avanir operates within relevant regulations.
As part of Quality organization, this position will be responsible
for planning, scheduling, communicating, conducting, and reporting
global GCP audits of Clinical Vendors, Investigators Sites,
Clinical Development and Operations, Data Management) in accordance
to global GCP regulations. This role may be required to provide
tactical and technical/operational guidance regarding GCP in
compliance with current regulations. The incumbent will work
closely with the Quality leadership and other cross-functional
Department Leaders in Clinical to communicate GCP Audit plans and
audit findings.Essential Job Functions and Desired
Accomplishments
- Develop audit plans and perform Quality audits of clinical
investigator sites, clinical vendors, data management, and internal
clinical systems/operations
- Document and report quality /compliance issues relating to the
clinical study, clinical trial material or clinical system
- Manage post-audit activities and follow-up on any necessary
corrective and preventive actions
- Gather and interpret regulatory intelligence, as well as
evaluate internal practices, make recommendations for improvement
and execute against action plans
- Interpret policies, standards and regulations and evaluate
potentially critical problems not covered by policies, standards
and regulations
- Exercise judgment in ensuring that written procedures are
followed
- Evaluate quality systems, processes, procedures and protocols
for compliance
- Develop internal SOPs, policies and procedures as
required------------------------------------------------------------------
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- Where required, draft quality agreements with Clinical
Vendors
- Track, trend GCP Audit KPI Metrics
- Escalate regulatory compliance risks to Quality and Clinical
Leadership to ensure that all issues are mitigated in a timely
manner.
- 30% travel both domestically and
internationallyEducation/Qualifications/Certifications (Knowledge,
Skills, Abilities, etc.) -
- BS/BA degree
- Certified Auditor is preferable
- 10+ years of experience in pharmaceutical industry
- 5+ years of experience in GCP auditing, GMP and GLP auditing
experience will be added benefit.
- Working knowledge of GxPs and quality systems
- Must be able to effectively collaborate with others and work in
a matrixed team
- Must be flexible, resourceful, and multitask efficiently
- Excellent project management skills is a mustPhysical
Requirements and Work Environment Physical Requirements:This
position primarily works in an office environment. It requires the
ability to sit or stand for long periods of time and frequent
walking. Daily use of a computer, phone, office equipment and other
computing and digital devices is required. May be required to stand
for extended periods when facilitating meetings or walking in the
facilities. Some local travel may be necessary, so the ability to
travel by plane, operate a motor vehicle and maintain a valid
Driver's license and/or effectively navigate public transportation
is required. While performing the responsibilities of the job, the
employee must be able to read and respond to interoffice
communications as well as effectively participate in meetings. The
employee is often required to sit and use their hands and fingers,
to lift up to 20 lbs., pull, push, carry, handle or feel. The
employee is required to carry, handle items, reach with arms and
hands, to stoop, kneel, or crouch; talk or hear. Mental demands may
require prolonged concentration, reading comprehension,
understanding and interpretation of concepts, ideas and
philosophies.-- The physical demands of the position described
herein are essential functions of the job and employees must be
able to successfully perform these tasks for extended periods.
Reasonable accommodations may be made for those individuals with
real or perceived disabilities to perform the essential functions
of the job described unless such accommodations would cause Avanir
an undue burden.Work Environment:While performing the
responsibilities of the job, these work environment characteristics
are representative of the environment the job holder will
encounter. Reasonable accommodations may be made to enable people
with disabilities to perform the essential functions of the job
unless such accommodations would cause Avanir an undue burden.
While performing the duties of this job, the employee is
occasionally exposed to moving carts, mechanical equipment
(copiers, computers, coffee machines) and vehicles. May be subject
to smells and odors. The noise level in the work environment is
usually quiet to moderate. The passage of employees through the
work area is average and normal.#MZ1#LI-Remote
Keywords: Otsuka Pharmaceutical, Trenton , Senior Manager, Quality Assurance GCP, Executive , Princeton, New Jersey
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