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.

Covers coordination of 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.

Responsibilities

• 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
• 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
• 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
• Makes sure budget, schedules, and 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, process’ and procedures. Previous managerial experience also required.

Qualifications

• ORMasters 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
• 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
• Creates a comprehensive audit program and carries 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
• Works 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
• Solid knowledge of all regulations pertaining to GxP’s and current industry trends as related to pharmaceutical, biological and gene therapy products
• Demonstrated analytical ability, strong leadership skills, exceptional communication skills, creativity, and the ability to effectively manage and implement multiple projects
• Expert at managing complex and multiple work streams in changing circumstances
• Promised leadership ability to identify, manage and develop QA teams

Skills

• In-depth knowledge of all Clinical Trial related FDA regulations, ICH Guidelines, and experience with international GCP regulations and guidelines is required
• Strong knowledge and expertise in GCP, as well as GLP and/or GMP systems throughout the product lifecycle
• Proven ability to cultivate and develop relationships with cross functional teams and vendors

Benefits

• The annual base salary we reasonably expect to pay is $181,800.00-$248,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
• This position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program.
• Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.