Director, Clinical QA

Neurocrine Biosciences • San Diego, CA

23h • $181,800 - $248,000

About The Position

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company has a diverse portfolio and a robust pipeline. Neurocrine emphasizes strong leadership that drives business results and team success, looking for leaders who think strategically, anticipate the future, set clear direction, and build/empower high-performing teams. This role is responsible for developing strategy and operating plans for Clinical QA, establishing compliance, procedures, and quality leadership. The Director will build and lead a team of quality professionals to implement quality systems, ensure compliance, and support clinical study teams. This role also leads the company through pre-approval inspections and clinical audits, coordinates interdepartmental activities, and ensures departmental 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, 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.

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 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.

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