Director of Quality Assurance

Overview

The Director of Quality is primarily responsible for overseeing the execution of the Quality Management System.

This includes oversight of all quality assurance and all quality control functions.

Ensuring compliance with cGMPs, policies, procedures and standards that are required to support manufacturing of active pharmaceutical ingredients and high-quality intermediates. He/she will also provide quality support for achieving key business objectives. This individual will participate in developing a quality culture that supports the company’s values of customer focus, integrity, collaboration, and innovation while meeting the needs of our stakeholders and regulators. The Director of Quality is responsible for productivity, tracked through metrics, and the

development/enhancement of the department’s staff using the performance management process.

The individual in this position will be responsible for quality oversight for drug substance manufacturing and release as well as other Quality support functions.

Responsibilities

The Director of Quality is responsible for providing technical understanding and communication (to various functions and organization levels as well as customer quality units and regulatory agencies) regarding the execution of the quality management system. He/she effectively influences the leadership on strategic direction and tactical implementation of the quality system. The individual in this role establishes the site’s quality objectives, priorities, and roadmap. They lead and oversee the inspection readiness program. He/she leads and/or participates in the assessment, development, and implementation of critical projects in support of continuous quality improvements. This may include new facility delivery or existing facility expansion/recapitalization.

The individual in this role has supervisory responsibilities providing both administrative and technical leadership to the site. This includes serving as the Site Quality Leader. The Quality Director leads and manages a team (10 people) including development and delivery of team objectives and individual quality system associate performance plans and objectives. He/she oversees daily work and provides direction on key priorities as needed. He/she determines and manages the work agenda and budget for the team. He/she provides leadership and direction in managing product-related quality matters,assuring the independence of the quality unit, while making decisions regarding quality issues. This individual ensures that the products are fit for their intended use and comply with local and international regulatory requirements. The Director of Quality ensures all required quality agreements are in place and maintained. He/she leads and responds to regulatory agency inspections and inquiries. He/she reviews/approves GMP documentation including procedures, training, master production records, technical protocols and reports, change proposals, deviations and corrective/preventive actions. This position reports functionally to Corporate Quality and hierarchically to the company Site Director.

Management & Organization

Stay true to the Company`s values of Integrity, Excellence and Respect of People. Make

sure employees are trained; follows the company's policies on ethics and compliance.

Ensure a safe and healthy work environment. Get strong participation from the Quality team

to HSE program. Monitor, verify, evaluate, and drive improvement towards site goals.

Ensure staff is qualified, that the initial & continuous training/ GMP education of all personnel is carried out as needed.

Develop people capability & knowledge (technical expertise, behavioral & managerial).

Ensure communication of the quality objectives and priorities to all site personnel.

Manage resources according to quality objectives, site priorities & anticipate future business

needs including headcount and finances.

Actively recruit, coach, and develop personnel within the quality unit.

Ensure that Quality activities are performed in accordance with procedural requirements and

meet planned timelines.

Provide administrative support & technical leadership to the site quality unit.

Quality Compliance

Assures the independence of the Site Quality Unit.

Ensures the development, adequacy, and effectiveness of the site’s quality management

system.

Ensures systems are in place to release or reject raw materials, intermediates, packaging

materials, components, and consumables.

Establish and ensure a system is in place for evaluating and releasing batch records in

accordance with regulations and company standards.

Ensure all necessary controls, testing, and monitoring are carried out with the quality control

function in accordance with the marketing authorization.

Ensure a system is in place for approving specification, sampling instructions, test methods

& batch records.

Ensure that all required quality agreements are in place & maintained.

Ensure site processes, equipment, instruments, utilities & facilities are qualified / validated

and maintained for the intended use.

Participate in approving Annual Product Reviews.

Ensure site audit & inspection readiness. Host audit & inspection. Assure timely closure of all

regulatory commitments.

Assure the adequacy & effectiveness of the site quality systems.

Participate on the Site Lead Team and lead the Quality Lead Team.

Ensure overall compliance with GMP regulations, Group’s Quality standards and

regulatory requirements through review and approval of GMP documentation.

Ensure the site has a process to maintain compliance status through gap assessment of

corporate and regulatory standards and guidelines.

Ensure adequate quality oversight on GMP documents and activities (e.g., through QA

presence on the shop floor).

Participate in project evolution and customer meetings.

Basic Requirements

Bachelor of Science degree or equivalent in a scientific field (e.g., chemistry, microbiology,

engineering)

Minimum of 10 years in the pharmaceutical industry

Minimum of 5 years of leadership experience in Quality Assurance &Quality Control

Additional Skills/Preferences

Proficiency with computer systems including Microsoft Office products

Demonstrated Technical writing ability

Demonstrated strong oral and written communication

Demonstrated ability in problem solving and critical decision-making

Demonstrated ability to coach, mentor and lead others

Demonstrated interpersonal skills with ability to influence cross-functionally and externally

Demonstrated self-motivated leadership, ensuring a fair and equitable work environment

Clear understanding of cGMPs, policies, procedures, and guidelines

Demonstrated ability to maintain a safe work environment

DEA compliance