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.