Director, Clinical QA

Neurocrine Biosciences • San Diego, CA

1d

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with neurological, psychiatric, endocrine, and immunological disorders. The company has a diverse portfolio of FDA-approved treatments and a robust pipeline. This role is responsible for developing strategy and operating plans for Clinical QA, establishing compliance, procedures, and quality leadership. The position involves building and leading a team to implement quality systems, ensure compliance, and provide QA support to clinical study teams. The Director will lead the company through pre-approval inspections and clinical audits, coordinate interdepartmental activities, and ensure department performance requirements are met.

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, processes, 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.

Responsibilities

• Develop and execute strategy for Clinical QA and establish strong, effective working relationships with internal and external stakeholders to achieve GCP compliance and Quality objectives.
• Lead the effort in developing, implementing, and communicating 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.
• Lead in the development, implementation, and enhancements to the clinical QMS.
• Participate in the evaluation, selection, compliance audit strategy, and oversight of global clinical investigators, contract clinical laboratories, and CROs.
• Monitor the regulatory status of principal investigators and intervene when sub-optimal performance is identified.
• Assist in remediation and corrective action plans to ensure all parts of the study are conducted properly.
• Support investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities.
• Develop metrics and trending of compliance activities for Clinical Quality Assurance and communicate these to upper management as necessary.
• Perform 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.
• Direct and oversee compliance activities related to drug safety and pharmacovigilance, phase IV studies, and investigator-initiated trials.
• Oversee and may perform 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.

Benefits

• Retirement savings plan (with company match)
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director