Clinical Trials QA Director

Job Description

Job Description

The Clinical Trials QA Director is responsible for setting the strategic vision for the global Clinical Quality function, aligning it with corporate objectives, risk tolerance, and evolving regulatory expectations. Acts as primary QA liaison to executive leadership, regulatory agencies, and external partners for clinical quality matters. Also, assures compliance of clinical development program with Good Clinical Practice (GCP), regulatory requirements (e.g., FDA, EMA, MHRA, ICH E6(R2)), and company SOPs. The role provides quality oversight of clinical trial operations, audits, ongoing CRO qualification and management, and inspection readiness, working closely with Clinical Operations, and CROs.

Some relocation may be available for this role.

Duties and Responsibilities (Responsibilities include but are not limited to) :

• Direct the design, implementation, and continuous improvement of the Clinical Quality Management System (CQMS) across all global clinical programs.
• Establish corporate GCP quality objectives, KPIs, and risk indicators; report to the executive team and board committees on quality performance and compliance trends.
• Oversee and approve the global GCP audit program, including strategic vendor qualification, investigator oversight, and emerging market entry readiness.
• Serve as the company’s lead representative for regulatory inspections globally, shaping inspection strategy, responses, and CAPA governance at the enterprise level.
• Chair cross‑functional quality governance forums to ensure alignment across Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Manufacturing QA.
• Sponsor initiatives for digital quality systems (eQMS, eTMF) optimization, leveraging data analytics for proactive compliance monitoring.
• Influence CRO / vendor quality expectations via contractual quality agreements and executive governance meetings.
• Shape company policy in response to new ICH guidelines and emerging GCP interpretations; lead global implementation strategies.

Supervisory Responsibilities :

Education / Experience / Skills :

Working Environment and Travel :

While performing the duties of this job, the employee is regularly required to walk, stand and sit.  The employee must regularly lift and / or move up to 10 pounds.  Specific vision abilities required by this job include close vision, peripheral vision, and the ability to adjust focus.

Normal office environment with some exposure to lab areas. The noise level in the working environment is usually moderate.

Occasional travel may also be expected, as needed.

ADA :

The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

SAB Bio is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB Bio is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE / AA / Vets

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