Director, Clinical QA

About The Role:

Responsible for developing strategy and operating plans for Clinical QA, and establishing compliance, procedures, and quality leadership. Responsible for building and leading a team of highly trained and skilled quality managers, specialists and associates in order to implement the quality systems and perform activities necessary to ensure compliance and to ensure QA support of clinical study teams. Leads the company through pre-approval inspections and clinical audits. Coordinates interdepartmental activities both internally and externally with regulatory, clinical, drug safety, and medical affairs to ensure clinical activities and internal functions meet quality standards and reflect risk-based principals. Ensures budget, schedules, and department performance requirements are met.

Your Contributions (Include, But Are Not Limited To):

• Develop and executive strategy for Clinical QA and establish strong, effective working relationships with internal and external stakeholders to achieve GCP compliance and Quality objectives

• Lead effort in developing, implementing and communicating of the GCP QA vision, goals, core capabilities, and value while championing a strong Quality Culture

• Partner with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs stakeholders regarding compliance issues and provide quality guidance and expert interpretation of GCP regulatory requirements and expectations

• Responsible for preparations and direct participation in regulatory inspections, which may include reviewing inspection readiness planning, mock inspections, performance of pre-approval inspections, and risk-based management of program inspection quality events

• Leads in the development, implementation, and enhancements to the clinical QMS

• Participates in the evaluation, selection, compliance audit strategy, and oversight of global clinical investigators, contract clinical laboratories, and CROs

• Monitors the regulatory status of principal investigators and intervenes when sub-optimal performance is identified. Assists in remediation and corrective action plans to ensure all parts of the study are conducted properly

• Supports investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities

• Develops metrics and trending of compliance activities for Clinical Quality Assurance and communicate these to upper management as necessary

• Performs investigator site and vendor audits to assess the integrity of the study data and to determine if studies are being conducted in compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures

• Directs and oversees compliance activities related to drug safety and pharmacovigilance, phase IV studies and investigator-initiated trials

• Oversees and may perform the internal audits designed to determine if policies/procedures, systems, reporting and/or the conduct of the investigational studies are executed with compliance to GCP principles/regulations

• Other duties as assigned

Requirements:

• RN, BSN, BS/MS, or BA degree or equivalent experience in scientific or health care field AND 12+ years of industry experience including GCP leadership roles within a development and commercial GCP environments. Extensive GCP audits and inspections or related experience required. Experience with developing and implementing GCP QA systems, process' and procedures. Previous managerial experience also required. OR

• Masters Degree in similar field as noted above AND 10+ years of experience as noted above

• Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization

• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively

• Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact

• Excellent interpersonal skills and competent confident communication when interacting with regulatory authorities as well as internal leaders and external partners

• Analyze complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups

• Ability to mentor, be a trusted advisor, and an advocate for Quality with the ability to influence change and invest deeply in the company mission

• Excellent relationship building and persuasion skills with the ability to motivate and influence others; demonstrated a record of overcoming resistance to change and driving the adoption of new processes from a position of indirect or informal authority

• Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, with an enthusiastic, optimistic outlook, and a collaborative style

• Ability to integrate and apply feedback in a professional manner

• Holds self and others accountable for adherence to high work and ethical standards

• In-depth knowledge of all Clinical Trial related FDA regulations, ICH Guidelines, and experience with international GCP regulations and guidelines is required

• Ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to investigator sites as well as management

• Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and implementation

• Broad understanding of domestic and international regulations and guidance documents, with a focus on FDA & EMA regulations

• Broad pharmaceutical industry experience with a working knowledge of quality systems and regulatory compliance requirements for clinical quality assurance

• Solid knowledge of all regulations pertaining to GxP's and current industry trends as related to pharmaceutical, biological and gene therapy products

• Strong knowledge and expertise in GCP, as well as GLP and/or GMP systems throughout the product lifecycle

• Demonstrated analytical ability, strong leadership skills, exceptional communication skills, creativity, and the ability to effectively manage and implement multiple projects

• Ability to solve problems and troubleshoot issues

• Expert at managing complex and multiple work streams in changing circumstances

• Proven ability to cultivate and develop relationships with cross functional teams and vendors

• Demonstrated leadership ability to identify, manage and develop QA teams