Lexington, Kentucky
Director of Quality Assurance Job Opening in Lexington, Kentucky - The Director of Quality is a strategic partner to the management team at our company. This Senior Level role must be able to articulate and achieve clear objectives as well as sound and effective processes. This role is responsible for leading and supervising quality strategy and execution within the company to direct good practices reducing risks on development of new technologies and collaborative projects within the organizational portfolio. This individual will work closely with the leadership team to foster, direct, and continually improve quality throughout the organization as well as cost and time factors consistent with our company's business objectives. Coverage of responsibility includes Quality Assurance, Document Systems, Quality Control, Microbiology, and Validation groups.
PRIMARY RESPONSIBILITIES
Ensure compliance with applicable internal and external regulations, standards, policies, and procedures related to quality and regulatory status and performance of company operations, processes, and products.
Represent company as the primary liaison with involved external regulatory and standards bodies (e.g. Food and Drug Administration-FDA). When necessary, adjudicate issues with product submissions, product performance, compliance concerns, and regulatory requirements.
Represent company as the primary liaison with involved client quality audits. When necessary, adjudicate issues with client and company's quality systems. Represent the organization's Quality Assurance department in project meetings.
Responsibility for the identification and escalation of emerging company compliance trends within organization; assist in developing strategies to mitigate or remediate trends.
Provide updates and recommendations to company quality council and company senior management staff with regard to status of such quality and compliance strategies, projects, and goals as related to cross-functional business objectives.
Work closely with the leadership team to foster and direct quality throughout the organization continually improving quality. Lead the quality culture by effectively utilizing departmental resources.
Responsible for development and execution of quality strategies and objectives within the organization.
Focus management on the appropriate metrics and actions based on those metrics across the organization assuring effective tracking of operational performance.
Ensure internal audit program is adequately defined and followed (inclusive of comprehensive CAPA development, approval, and execution) in a timely and effective manner.
Conduct external audits as required.
Ensure product is released in a timely manner in compliance with company procedures and regulatory requirements.
Define and approve departmental budget and capital expenditures.
Exercise independent action in hiring and firing personnel within established company policy and procedures.
Lead and mentor quality assurance and document system staff.
Ensure company's document control is within regulatory and company policies and procedures.
Attendance of industry conferences to stay informed of current industry trends and expectations is required.
Continually seek industry recognized certifications such as CQA, CPGP, or RAPS.
QUALIFICATIONS
Bachelor of Science Degree in a related field, advanced degree preferable
A minimum of ten years? experience in Pharma QA leadership role
Extensive experience in Aseptic/Parenteral pharmaceuticals is required
FDA auditing experience mandatory.
Background in global QS and international management recommended.
Job Type: Full-time
Salary: $160,000.00 to $180,000.00 /year
Required education:
Bachelor's
Required experience:
Pharma QA Leadership role: 10 years
Aseptic/Parenteral pharmaceuticals is required: 5 years
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