Associate Director, Quality Systems and Compliance

Serán is seeking an Associate Director, Quality Compliance who will be responsible for leading the Quality Compliance program to ensure ongoing adherence to applicable GxP regulations, client requirements, industry standards, and internal Quality Management System (QMS) requirements. This role serves as the primary owner of inspection readiness, regulatory inspection management, client audit support, internal audit programs, supplier quality oversight, management review, quality metrics, and compliance monitoring activities.

The Associate Director partners closely with Manufacturing, Quality Control, MSAT, Supply Chain, Regulatory Affairs, Engineering, Validation, and Quality Systems to foster a proactive quality culture and ensure sustainable compliance as the organization advances commercial manufacturing capabilities. This position serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to cGMP compliance oversight.

• 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

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.

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.

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).

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