Director, Quality

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

Responsible for cGMP compliance and product quality at the Port Allen, LA facility as well as participation in additional site quality initiatives in support of site and company quality objectives. This position also provides professional competence and management level leadership in the establishment, maintenance, function, and review of site quality systems to assure that all activities involved in the manufacturing, analysis, packing, storage, and distribution of pharmaceutical and medical device products are conducted in a manner that ensures product quality and cGMP compliance and that all equipment, systems, and materials used in the process are adequate to ensure the same. The Director, Quality oversees quality personnel who coordinate/manage the day-to-day activities related to the quality assurance and quality control departments and provide guidance for site personnel pertaining to quality and compliance.

• Manage a staff of supervisors and employees by ensuring all personnel are adequately trained and competent to fulfill the duties of their positions.
• Sets the goals and objectives and quality objectives for the Port Allen quality department and site, respectively and performs performance management activities to provide feedback to staff.
• Ensure department work areas are maintained in a manner that is safe, clean, orderly, and compliant.
• Assures site quality activities and the quality system comply with applicable regulations and standards (FDA, cGMP, OSHA, EPA, ISO, etc.) and with company policies and procedures.
• Supports the Port Allen site through documentation review and approval, project reviews, improvement plan creation (based on metric reviews), and other activities as necessary.
• Facilitates all external audits and regulatory inspections performed at the Port Allen, LA.
• Prepares the Port Allen quality department's annual budget, as required.
• Support the development of staff through development plans and personnel assessments.

Education / Experience / Skills:

• Bachelor's Degree or higher
• 10 years minimum experience in Pharmaceuticals and/or Medical Devices

Competencies:

• Working knowledge of Regulations & Compendium Reference Materials
• Superior working knowledge of cGMPs
• Superior working knowledge of regulated site processes
• General knowledge of standard quality techniques
• Effective interpersonal skills
• Capable of excellent teamwork
• Effective Leadership skills
• Capable of motivating and developing employees and influencing others
• Effective written and oral communication skills
• Effective organizational skills
• Demonstrated abilities in working with Regulatory Agencies in inspections
• Strong financial acumen, demonstrated strategic planning skills, and the ability to successfully communicate in a global organization.
• Extensive experience with manufacturing process improvement, including budget management, facility enhancement and improvements, lead time reduction, workflow enhancements and capacity management planning.

Reports to the Vice President, Global Quality. This position directly supports Manufacturing, Materials Management, Quality Control, Product Monitoring, Compliance functions and Supply Chain functions.

The position typically works in an office setting, with interaction in the manufacturing areas.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.