Basic Purpose: The Senior Director, Quality Operations will suppor
t quality initiatives and ensure compliance with cGMP's are maintained at the manufacturing facility.Essential Functions and Responsibilities:- Provides leadership and direction to the Quality organization.
- Provide mentorship, oversight and development for the Quality Assurance, Quality System, Quality Affairs, and Quality Control staff.
- Makes decisions focused on key quality strategic and operational matters that have significant, direction setting impact on the company.
- Directs and controls the activities and outcomes of Quality Assurance which has a significant organizational and product impact.
- Sets and aligns goals and objectives for the Quality Assurance department with the overall corporate goals and objectives.
- Oversee preparation, coordination and execution of all regulatory inspections with the FDA or other regulatory agencies.
- Develop and maintain external relationships with key opinion leaders and regulatory officials.
- Direct the development of systems, practices, and processes to ensure effective ongoing review of product design and/ or manufacturing changes.
- Provide leadership and direction for significant deviation events that may impact compliance status or significant business risk.
- Oversee the functions of the analytical and microbiology laboratory, including:
- Release of raw materials and components
- In-process testing
- Finished product release testing
- Stability testing
- Environmental Monitoring
- Review and approve quality documents, including:
- Deviations
- Annual Product Quality Reviews
- Customer Complaints
- Validation Protocols/Reports
- Change Controls
Knowledge, Skills, Qualifications and Physical Requirements:Education/Training/Work Experience:- A Bachelor's Degree or higher degree in life sciences, engineering, or business
- 15+ years pharmaceutical quality experience in a manufacturing, CMO, or life sciences technology driven company.
- Analytical and Microbiological proficiency related to the methodology of semi-solids drug products and associated excipients
- Extensive experience in cGMP and other Regulatory compliance requirements.
- Progressive and proven record of leadership and managing quality/ analytical organization's establishing long term strategic growth initiatives.
- Experience with phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization.
- Ability to lead, influence, create and work within cross-functional team environments.
