Overall responsibility for leading the company product quality systems, including the setting of quality goals, managing and improving all aspects of the quality system and product quality and oversee company’s quality control, quality assurance, regulatory and compliance functions.
Essential Duties and Responsibilities:
Ensures compliance with applicable internal and external regulations, standards, policies and procedures related to the quality and regulatory status, performance of company operations, processes and products develops a company-wide quality improvement plan. Develops implements and monitors progress against the company’s strategic quality plan, related quality objectives, projects and goals for associated departments. Provides update and recommendation to the company senior management staff with regard to the status of such objectives, projects and goals as relate to cross-functional business objectives. Maintains contact with critical vendors, professional organizations, consultants and peers in order to be current with prevailing industry standards. Represents company as the primary liaison with involved external regulatory and standards bodies (e.g. Food and Drug Administration (FDA), consumer product safety commission (CPSC), when necessary to adjudicate issues with product submissions, product performance, compliance concerns and prevailing or impending regulatory requirements. Ensures internal and external audit program is adequately defined and followed (inclusive of comprehensive CAPA development, approval and execution) in a manner that is both timely and global in nature. Ensures efficient and effective validation programming and execution for manufacturing processes, test methods, software, cleaning and facilities, equipment or utilities by employment of a comprehensive validation master plan. Ensures product is released in a timely manner in compliance with company procedures and regulatory requirements. Ensures that all quality related laboratories (both within company as well as those that perform contract testing for company) operate in an efficient and safe manner in accordance with cGMP and OSHA requirements. Defines and approves departmental budget and capital expenditures. Assists the Compliance Manager in the development of a corporate compliance plan. Works with directors and teams to assess and ensure compliance with quality improvement and compliance plan against internal (policy/procedure) and external (contract/program) requirements; report regularly on results. Organizes and facilitates regularly scheduled compliance training with directors, team leaders and staff needed to educate and implement quality and compliance as a strategy. Assists with development training for all employees in quality improvement principles and compliance requirements.
A minimum BS (Chemistry, Biology or related Life Sciences) M.S. or M.B.A. preferred, a minimum 15+ years of senior quality leadership in pharmaceuticals, experience in strategic planning and collaboration with executive and key operational groups, progressive and proven track record of leadership and managing quality/regulatory organization’s with international responsibility and establishing long term growth initiatives, experience in all phases of the product development life cycle, including concept, design, implementation, verification and validation activities necessary for product commercialization, extensive experience in pharmaceutical cGMP’s and other regulatory compliance requirements.
Required Knowledge, Skills and Abilities:
A high level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction, excellent communication and interpersonal skills, ability to develop and manage a high performance team focused on accountability and meeting and exceeding expectations, ability to lead, influence, create and work within cross functional team environments, assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude and a sense of urgency to get things done.