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Sr. Manager, Associate Director, Clinical Quality Assurance
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 Department.
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 issues.
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 quality principles.
Participate in corporate and departmental meetings.Comply with applicable regulations, GCP and corporate policies and procedures.
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 interpersonal skills.
Ability to successfully manage a full workload across multiple projects.
Demonstrated analytical, problem solving and decision-making skills.
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 email@example.com with a cover letter and CV.
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