Reata Pharmaceuticals, Inc. has an opening in Irving, Texas for
a Sr Manager or Associate Director of Clinical Quality
Assurance (QA) in our growing and dynamic Regulatory
Reata Pharmaceuticals, Inc. is a biopharmaceutical company
dedicated to the discovery, development and commercialization of
new drugs that target major unmet clinical needs in kidney disease,
inflammation and neurodegenerative diseases. Reata is located in
the attractive northwest suburbs of Dallas, TX.
Sr. Manager/Assoc. Director, Clinical Quality Assurance (QA) will
support pre-clinical, clinical and pharmacovigiliance activities,
including development and management of a quality assurance (QA)
audit program for those activities. The individual will
prepare the company, various trial sites and vendors for regulatory
authority inspections; participate in inspection teams, as
appropriate; review and recommend compliance-related policies and
procedures. He/she will provide GxP training and mentoring;
evaluate impending regulations, guidelines and industry standards
and their impact on clinical trials and the company; and assist in
management of Clinical QA consultants. Note: this position requires
up to approximately 10% travel.
The Sr. Manager/Assoc. Director will personally conduct or
supervise conduct of the following:
QA audits of clinical trials, including but not limited to,
clinical investigator site audits, vendor audits, and internal
clinical system, process and document audits to verify adherence to
good clinical practice (GCP) and Reata quality standards.
QA audits of preclinical facilities, studies and activities, to
verify adherence to good.
QA audits of pharmacovigiliance (PV) activities, including PV
system, process and document audits.
Conduct will include planning, scheduling, reporting and closing of
audits as well as the actual audit conduct.
In addition the Sr. Manager/Assoc. Director will be responsible for
the following activities.
Manage program/project-specific audit plans.
Manage contracts and performance of vendors conducting audits
on behalf of Reata.
Act as a subject matter expert for GCP, GLP and/or PV issues
and provide expert support for the company.
Oversee documentation, reporting, and closure of compliance
Generate and review SOPs.
Conduct Quality review of reports of clinical and nonclinical
studies, and clinical, nonclinical and pharmacovigiliance portions
of regulatory submissions, including Investigator Brochures.
Ensure proper coordination of mock regulatory inspections,
internally and externally.
Conduct research and provide guidance, interpretation, support,
training, and key input to clinical development operational staff
on interpretation of GCP regulations, guidelines, corporate
standards, and policies.
Support Functional Head of Quality Assurance in proposal
reviews and reporting QA metrics.
Demonstrate commitment and support for company goals,
objectives and procedures.
Represent Reata by developing collaborative relationships with
site personnel, colleagues and vendors.
Demonstrate professionalism and adherence to moral, ethical and
Participate in corporate and departmental meetings.Comply with
applicable regulations, GCP and corporate policies and
Bachelor's/primary degree in life sciences or medically related
field; or equivalent paramedical qualifications.
At least 5 to 7 years Clinical Quality Assurance experience in
pharmaceutical, technical, or related area, including planning and
performing internal and external GCP audits.
Extensive knowledge and understanding of GCP regulations.
Working knowledge of either GLP, PV or computer system
validation (CSV) regulations.
SOP development experience.
Solid understanding of quality management and continuous
process improvement principles.
Excellent written and oral communication skills and
Ability to successfully manage a full workload across multiple
Demonstrated analytical, problem solving and decision-making
Ability to effect change within an organization.
A flexible attitude with respect to work assignments and
continued industry related education.
Ability to work in a matrix environment and to value the
importance of teamwork.
Strong training skills.
In addition to competitive salaries and a challenging work
environment, we offer a comprehensive benefit package including
medical, dental, vision, STD/LTD, life and a 401(K) saving
program. We offer a generous Health Savings Account funded by
the company. Must be legally authorized to work in the U.S. without
sponsorship. Reata Pharmaceuticals is an Equal Opportunity
employer. Apply to firstname.lastname@example.org
with a cover letter and CV.
Reata Pharmaceuticals Inc. - 2 years ago
Reata Pharmaceuticals, Inc. is a biopharmaceutical company focused on selecting promising early drug development opportunities and...