Director of Quality Assurance

Job Purpose:

The Director, Global Quality Assurance is accountable for the implementation,

maintenance, monitoring, and effectiveness of the overall Quality Management

System (QMS). This role drives Quality System and departmental strategy

development to ensure alignment with the company’s annual and long‑term

global goals. Ensures sites and processes are maintained in a constant, audit

ready (regulatory and customer) state. Delivers and promotes a positive quality

culture at all levels of the company.

Duties and Responsibilities:

• Apply Good Manufacturing Principles (GMP), Good Distribution Practices

(GDP), Good Clinical Practices (GCP), and other relevant GXP in all areas of

responsibility.

• Develop, review, revise, distribute, and train Standard Operating Procedures

(SOPs) and associated documents.

• Conduct and or direct risk-based quality event (e.g., deviation, complaint,

nonconformance) investigations and determine/implement corrective actions

to correct immediate issue and prevent recurrence.

• Maintain records of quality events for internal and external reporting. Track

and trend data.

• Partner with and effectively influence operations teams to embed procedural

compliance and quality into daily transactional activities, ensuring all

processes contributing to the performance of company activities are

conducted according to requirements.

• Provide guidance to operations teams for proper product classification (e.g.,

medical device, drug product) and associated regulatory requirements (e.g.,

CE Mark).

• Oversee and manage the change control system including documentation and

filing as may be required.

• Facilitate and or perform internal, supplier, and customer audits.

• Serve as the primary point of contact for customer audits and regulatory

inspections.

• Plan, coordinate, and manage the recall process.

• Plan, schedule, and lead Management Review per procedural requirements.

• Monitor facility pest control service reports.

• Oversee the equipment qualification and calibration program for equipment

used in all Ancillare operations.

• Review and approve computer system validation documents.

• Manage and support facility qualification activities such as temperature

mapping and monitoring of controlled environments.

• In collaboration with Legal, oversee the application, maintenance, and renewal

activities for quality / regulatory licenses, registrations, and/or certifications.

• Develop and implement training for employees on compliance with Quality

System standards improving worker performance, knowledge of and support

of a quality focused job.

• Oversee the management and maintenance of training files ensuring that

accurate, complete, and up to date files are maintained for all employees and

contract workers.

• Ensure the development and deployment of Training Matrixes for new and

transferred employees.

• In collaboration with senior leadership strategize process improvements to

increase quality levels, ensure safety, reduce waste, and increase profitability.

• Deploy process improvements driving increased awareness and measure

milestone results.

• Develop, maintain, and provide to senior leadership realistic and meaningful

quality metrics to drive continuous improvements.

• Develop and maintain supplier and customer Quality Agreements.

• Oversee supplier approval process.

• Hire, train, supervise and mentor global quality staff.

• Ability and desire to work a project to completion meeting and or exceeding

timeline deliverables.

• Demonstrate and drive the Ancillare mission, values, and strategy.

• International travel as may be required.

• Other duties as may be assigned.

Qualifications:

• BS/BA degree required preferably in Life Sciences or engineering, may

consider equivalent work experience in a CRO or comparable environment.

• 7+ years’ experience in quality assurance within a contract research

organization, clinical supply chain, or comparable environment with clear

career progression.

• Previous experience with contract packaging, supply chain compliance, or

ancillary support highly desirable.

• Working knowledge of global regulatory compliance for drug product and/or

medical devices is highly desirable

• Ability to travel internationally as may be required.