Associate Director, Quality Systems and Compliance

Your tasks

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.

Requirements

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).

Other

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