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Director of Clinical Quality Assurance

Protrials

This is a Full-time position in Remote, OR posted March 5, 2021.

We opened our doors with a clear and simple vision: to provide the worldwide clinical research industry with professional services that demonstrate the highest level of experience, quality, and integrity. Since 1996, ProTrials has supported research that has led to ground-breaking treatments and solutions in the pharmaceutical, biotechnology, and medical device industries.What fuels our focus? Most of us entered the clinical research field to help patients, caregivers, or maybe even our loved ones. We show up every day committed to do work that matters. When you join ProTrials, you will join a collaborative community helping to build a healthier world.We also understand your need to balance a meaningful workload with life’s every-day moments. At ProTrials, we know that this makes our employees happier, healthier, and more successful.The Director of Quality Assurance (Director, QA), is responsible to develop, establish and oversee ProTrials clinical QA systems and processes to ensure high quality client services, clinical research processes and compliance with regulatory requirements. Ability to communicate a clear strategic vision for QA and ability to anticipate and prevent quality and/or regulatory problems. The Director, QA will perform the following essential duties either directly or through the appropriate use of resources including, direct reports, indirect reports, or consultants.ESSENTIAL DUTIES* Leads departmental strategic planning and goal setting that meet compliance requirements and business needs* Sets clear objectives for performance and accountability for the QA team* Manages company Controlled Documents system (Standard Operating Procedures SOP, Guidelines, and Policies)* Manage and/or conduct QA audits of internal clinical processes and ProTrials vendors* Manage corrective and preventative action program, including communication to senior management and clients, as appropriate* Manage corporate training files (tracking, filing) processes and training related to client and agency inspections* Prepare staff for client audits and Health Authority inspections, management of the audit/inspection process, and provide/review corrective and preventative action responses associated with audits/inspections* Coordinate and provide GCP training to ensure that staff is up to date on required regulatory requirements and trends* Keep abreast of regulatory updates and is a resource for improving processes; communicates information to staff either through training programs or other communication channels* Work closely with the senior management team regarding quality processes, issues, resolution, and documentation* Drive growth and organizational change within the Quality Assurance department to meet corporate business goalsOTHER QUALIFICATIONS:* History of effective cross department collaboration with successful business outcomes* Demonstrated interpersonal and leadership skills* Excellent communication skills to effectively influence all levels of organization in diverse situations including conflict resolution and problem solving* Extensive knowledge of industry regulatory requirements, and GCP* High level of computer expertise including standard programs, an understanding of IT as related to security and quality systems* Good comprehension of risk management strategies and business principles. Demonstrated experience in negotiation and persuasion skills* Demonstrated ability to make sound judgments/decisions* Excellent written and verbal communication skills, including presentation and analytical reportingEDUCATION AND/OR EXPERIENCE:* 10+ years of quality-related experience in the clinical research, medical device, or pharmaceutical industry* 5+ years of demonstrated successful team and/or department leadership* BS, BA, or other 4-year degree required, preferably related to business, STEM or quality systems* Current education or training related to quality management and/or membership in a quality-focused organizationPERKS AND BENEFITS* Competitive pay* Career growth* Full medical, dental, and vision benefit packages* 401(k)* Commuter benefits* Legal benefits* The best coworkers, if we we do say so ourselvesProTrials Research, Inc. is an equal opportunity employer. ProTrials does not discriminate against qualified applicants or employees with respect to any terms or conditions of employment based on race, color, citizenship status, national origin, ancestry, gender (including gender identity and gender expression), pregnancy, and childbirth or related medical conditions (including genetic characteristics), genetic information, sexual orientation, age, religion, creed, physical or mental disability, medical condition, military or veteran status, marital status, political affiliation, or any other characteristic protected by state or federal law.

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