Senior Director, Quality Assurance Systems

Job Summary:

Reporting to the VP Quality, the Senior Director, Quality Assurance Systems will have responsibility for Commercial and R&D activities that span manufacturing, packaging, laboratory, warehouse, IT, and External Quality operations.  The Senior Director, QA Systems will oversee the development, implementation and maintenance of the Company’s global GxP quality management system to comply with applicable laws and regulations, ensure compliance through training and regular management reviews including quality metrics, and direct the functional resources needed to execute this strategy. Establishes effective processes, procedures and systems to maintain overall quality compliance, monitor trends, and recommend continuous improvement programs to improve sitewide compliance and operational efficiencies.  Ensure the organization remains in an Inspection Readiness state by managing the internal audit program and providing a leadership role in partner audit and regulatory inspections.

Supervisory Responsibilities:

• Directly manage personnel across Document Control, External Quality and Quality System departments.
• Set performance goals, monitor progress, and provide regular coaching, feedback, and performance evaluations.
• Develop, mentor, and retain team members by fostering a culture of accountability, collaboration, and continuous improvement.
• Ensure staffing levels, training, and professional development to meet departmental objectives and support long-term succession planning.
• Delegate assignments, establish priorities, and oversee daily workflow to ensure timely and compliant execution of QA responsibilities.
• Lead by example to reinforce a Quality-focused culture aligned with company values, regulatory requirements, and business objectives.
• Manage cross-functional communication within QA and other departments to resolve issues efficiently and promote a collaborative work environment, driving continuous improvement objectives.
• Address employee relations matters in accordance with company policy, including conflict resolution, corrective actions, recognition of achievements, and organizational development and employee retention efforts.
• Support change management by guiding staff through organizational and regulatory transitions with clarity and maintain an engaged and responsive Quality Culture through team building and cross-functional initiatives.

Duties and Responsibilities: 

• Provide guidance and support utilizing risk-based decisions required for material, batch and finished good product disposition according to cGMP requirements.
• Ensure the organization remains in an Inspection Readiness state by managing the internal audit program and providing a leadership role in partner audit and regulatory inspections.
• Oversee document control system for the approval and issuance of finished product, batch records and specifications to ensure appropriate life cycle management.
• Ensure facility and equipment maintenance, engineering control, environmental monitoring, and preventative maintenance systems are effective in accordance with government regulations.
• Lead Quality Council management meetings and provide routine Quality metric reporting and identify areas for continuous improvement or escalation to management. 
• Maintain the Risk Registry Report and establish a prioritization matrix to mitigate and remediate issues and assign CAPA as needed for documentation of related activities.
• Manage GxP related manuals, policies, processes/procedures, batch records and work instructions and ensure data integrity and ALCOA practices and oversee the Internal Audit Program to monitor compliance. 
• Lead the Change Approval Board (CAB) for change requests and support a cross-functional process for a holistic assessment required to review and approve change requests.  
• Utilize CAB process for new supplier, laboratory and service providers and update the Approved Supplier Listing as needed utilizing Vendor Audits, SAP Item Master approval, Quality Agreement and follow-up on Supplier SCARs as required.   
• Maintain current with and share industry trends and regulatory expectations to ensure evolution of the Quality Management System and compliance strategy. 
• Establish and maintain a positive working relationship within the Company and with their external business partners as it relates to area of responsibility. 
• Other duties as needed.

Required Skills/Abilities:

• Strong ability to analyze complex issues required for quality system assessments including effective deviation root-cause determinations, CAPA assignment, change request content, customer complaint review, and risk-based decision making for product disposition.   
• Possess strong conflict management and negotiation skills. 
• Excellent verbal and written communication skills

Education and Experience:

• The ideal candidate will have experience in pharmaceutical quality assurance and will have several positions with increasing levels of responsibility throughout their career.  
  • Bachelor’s degree or related science discipline required; Advanced degree (MS, PhD, MBA) preferred.

• 15 years of experience working in the pharmaceutical industry with at least 10 years in leadership role managing quality. 
• Experience in multiple disciplines within Quality (e.g. auditing, investigations, complaints, cGxP oversight, electronic systems management, PAI inspection, commercialization and leadership).
• Must have in-depth knowledge and experience interpreting FDA guidelines and have a proven track record in implementing these guidelines in fast paced environments.  Experience with FDA and/or DEA Agency Inspections serving as a subject matter expert or direct interaction during the inspection is highly desirable.
• Experience overseeing cGMP related quality systems, policies and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
• Demonstrated leadership successes in building and creating cross-functional teams and developing a quality culture infrastructure. 
• Experience with External Quality including CMO providers and Supplier Management is desirable.  

Physical Requirements/ Working Conditions: 

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

PAI Pharma is a nicotine-free campus, meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances—is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.  Is this necessary, seems inconsistent with similar company recruitment efforts.

EEO Employer / Veteran / Disabled