Associate Director, Quality Systems and Compliance

Leader Responsibilities • Leads and develops a high-performing Quality organization

• Provides mentoring, coaching, and professional development for technical staff; provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy

• Establish clear departmental goals aligned with organizational quality and operational objectives

• Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications

• Fosters a culture of quality ownership, compliance, and continuous improvement

• Oversees daily workflow of the department

Duties & Responsibilities • Lead the site's inspection readiness program and maintain a state of continuous readiness.

• Monitor evolving regulatory expectations and assess potential impacts to the Quality Management System.

• Conduct routine compliance assessments to identify gaps and opportunities for improvement.

• Drive remediation activities associated with inspection observations, compliance risks, and quality system weaknesses.

• Support implementation of compliance initiatives necessary to maintain commercial manufacturing readiness.

Regulatory Inspection Management:

• Serve as Quality lead for health authority inspections.

• Coordinate inspection preparation activities across all functional areas.

• Lead inspection logistics, document management, response coordination, and inspection support activities.

• Facilitate timely and effective responses to regulatory observations.

• Track regulatory commitments through completion and effectiveness verification.

Client Audit Program:

• Manage customer audit preparation and support activities.

• Partner with clients to facilitate quality due diligence, qualification, and surveillance audits.

• Coordinate audit logistics and observation responses.

• Track completion of corrective and preventive actions resulting from client audits.

• Trend audit observations to identify recurring compliance risks.

Internal Audit Program:

• Develop and maintain the annual internal audit schedule.

• Execute risk-based internal audits across manufacturing, laboratory, warehouse, engineering, supplier quality, and quality systems functions.

• Assess effectiveness of quality system implementation and compliance.

• Communicate audit findings and recommendations to management.

• Verify implementation and effectiveness of corrective actions.

Supplier Quality Management:

• Manage the Supplier Qualification Program.

• Ensure risk-based qualification and monitoring of suppliers, contract laboratories, consultants, contractors, and critical service providers.

• Review supplier performance metrics and quality trends.

• Coordinate supplier audits and periodic evaluations.

• Support quality agreements and supplier quality governance activities.

• Escalate supplier-related quality risks to management.

Quality Metrics & Management Review Program:

• Coordinate and facilitate Site Management Review processes.

• Compile quality system performance data and compliance metrics.

• Present key compliance trends, risks, and quality indicators to leadership.

• Track management review actions through closure.

• Ensure management review activities support executive decision-making and resource planning.

• Develop and maintain compliance dashboards and performance metrics.

• Trend quality system performance and identify emerging compliance risks.

• Monitor key performance and compliance indicators including.

• Provide routine compliance updates to site leadership.

• Participate in development of annual quality objectives.

• Monitor quality system health and identify compliance trends requiring escalation.

• Provide compliance guidance to cross-functional teams.

Compliance Governance & Risk Management

• Support and maintain the site’s Data Integrity Compliance Program

• Provide assessments of computerized systems and data governance controls

• Participate in investigations involving data integrity concerns

• Promote risk-based decision making throughout the organization.

• Facilitate quality risk assessments related to compliance, product quality, and patient safety.

• Ensure risks are appropriately documented, mitigated, and escalated when necessary.

• Support implementation of ICH Q9 principles within quality systems and operations.

Required Skills & Abilities • Broad knowledge of FDA and international regulations related to cGMPs and commercial drug product manufacturing.

• Experience organizing and managing work responsibilities while working independently with minimal oversight.

• Time and project management skills with the ability to multi-task and meet deadlines.

• Excellent verbal and written communication skills. 

• Excellent interpersonal and customer service skills. 

• Excellent organizational skills and attention to detail.

• Strong analytical and problem-solving skills.

• Strong supervisory and leadership skills.

• Ability to prioritize tasks and to delegate them when appropriate. 

• Proficient with Microsoft Office Suite or related software.

Education & Experience • Bachelor's Degree in Life Sciences, Chemistry, Microbiology, Engineering, Pharmacy, or related discipline required. Advanced degree preferred.

• Minimum 8 years of pharmaceutical, biotechnology, medical device, or CDMO quality experience.

• Minimum 3 years of leadership experience within Quality Compliance, Quality Systems, or related quality functions.

• Experience in supporting commercial manufacturing operations required.

• Experience supporting FDA and / or EU regulatory inspections.

• Demonstrated knowledge of cGMP regulations and quality system requirements.

• Experience with electronic Quality Management Systems (eQMS).

Physical Requirements • Prolonged periods of sitting or standing at a desk and working on a computer.

• Must be able to lift up to 15 pounds at times.

• Adheres to consistent and predictable in-person attendance