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