Associate Director Quality

SUMMARY:

The Associate Director of Quality is responsible for providing strategic and operational leadership of the site's Pharmaceutical Quality System (PQS), ensuring compliance with global regulatory requirements, customer expectations, and company standards. This role serves as the senior quality leader for the site and is accountable for fostering a culture of quality, continuous improvement, risk management, and inspection readiness across the operations.

The Associate Director of Quality provides independent oversight of quality systems and product quality decisions, partnering closely with Operations, Mechanical & Engineering Services, Supply Chain, Project Management, and Commercial teams to ensure the successful delivery of compliant products and services to customers.

This position serves as the primary quality representative during customer engagements and regulatory inspections, ensuring effective communication, issue resolution, and sustained regulatory compliance while supporting the site's business objectives and growth strategy.

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

The following is a list of minimum responsibilities related to the Associate Director of Quality position. Other duties may also be assigned.

Quality Leadership and Governance

• Provide overall leadership and strategic direction for all site Quality functions, including Quality Assurance, Quality Systems, Compliance, and Validation.
• Serve as the site's senior Quality authority, ensuring independent and objective quality oversight in support of patient safety, product quality, and regulatory compliance.
• Establish and maintain an effective Pharmaceutical Quality System that meets applicable cGMP, regulatory, customer, and corporate requirements.
• Develop and execute the site's Quality strategy, goals, and improvement plans in alignment with site and global business objectives.
• Promote a proactive quality culture that drives accountability, ownership, continuous improvement, and operational excellence throughout the organization.
• Act as a key member of the site leadership team, contributing to strategic business decisions and site performance initiatives.

Quality Systems and Compliance

• Ensure the effective management of quality systems, including deviations, investigations, CAPAs, change controls, complaints, risk assessments, document control, supplier quality, training, and management review.
• Oversee the timely investigation and resolution of quality events, ensuring robust root cause analysis and sustainable corrective and preventive actions.
• Monitor quality metrics and performance indicators, identify emerging trends and risks, and implement actions to improve overall quality performance.
• Ensure ongoing inspection readiness through routine monitoring, internal audits, management reviews, and compliance assessments.
• Lead quality risk management activities and support data-driven decision making across the organization.
• Ensure the effectiveness of training programs and personnel qualification systems to maintain a highly competent and compliant workforce.

Regulatory and Customer Engagement

• Serve as the primary quality representative during regulatory inspections, customer audits, corporate assessments, and due diligence activities.
• Lead inspection preparation, inspection management, response development, and post-inspection remediation activities.
• Maintain strong and collaborative relationships with customer quality organizations, addressing quality issues proactively and ensuring effective communication and resolution.
• Provide quality oversight and assessment for new business opportunities, technology transfers, new product introductions, and ongoing customer programs.
• Evaluate evolving regulatory expectations and industry’s best practices and ensure their effective implementation at the site.

Operational Quality Oversight

• Partner with cross-functional leaders to ensure quality requirements are fully integrated into manufacturing, packaging, testing, warehousing, engineering, validation, and supply chain activities.
• Provide quality guidance and risk-based decision making to support operational performance while maintaining compliance and product quality.
• Support the introduction of new technologies, systems, and processes through appropriate quality oversight, validation, and change management.
• Drive continuous improvement initiatives focused on simplification, compliance, efficiency, and customer satisfaction.

Talent Development and Organizational Capability

• Lead, develop, and mentor the Quality organization, creating a high-performing team capable of meeting current and future business needs.
• Establish clear objectives, performance expectations, and development plans for Quality personnel.
• Build succession plans and organizational capability to ensure sustainable leadership and technical expertise within the Quality function.
• Foster employee engagement, collaboration, and professional growth while reinforcing company values and behaviors.

Additional Accountabilities

• Accountable for final quality disposition decisions and escalation of significant quality risks to senior leadership.
• Ensure adequate resources, systems, and infrastructure are in place to support business growth and maintain a state of control.
• Lead site Management Review processes and communicate quality performance, compliance risks, and improvement opportunities to executive leadership.
• Champion operational excellence and quality transformation initiatives that enhance both compliance and business performance.
• Serve as the site advocate for patient-centric quality practices, ensuring decisions prioritize patient safety, product quality, and regulatory integrity.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Demonstrated knowledge and application of FDA cGMP/GCP regulations, EMA, ICH, and other international regulatory regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 compliance in a manufacturing/packaging setting.
• Demonstrated history of team management and effecting cross-functional change with strong problem solving and interpersonal skills. 
• Excellent verbal/written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non-technical audience. 

SUPERVISORY RESPONSIBILITIES:

The candidate will be responsible for direct supervision of the entire quality organizations at the facility.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

Based on requirements that are job-related and consistent with business necessity.

• Bachelor’s degree in science (BS/BA) from a four-year college or university preferred; or five to seven years-related experience and/or training, or equivalent combination of education and experience.
• Knowledge of FDA regulations including cGMP and current industry practice.
• Thorough knowledge of quality control/assurance and/or operations
• Knowledge of DEA regulations
• Broad knowledge of current pharmaceutical industry trends including packaging and medical device practices
• Must have strong communication, interpersonal, and management skills.
• Ability to multi-task and methodically manage activities in a fast-paced manufacturing, packaging and device assembly environments.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.

Travel to customers on an as needed basis.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.