Director of Quality

1 month ago

Mead, United States Molecular Search Full time

SUMMARY: As a member of the leadership team, the Director of Quality will develop quality strategies for the Quality Department, Quality Control, and Quality Assurance, to include testing, documentation, compliance, and release of product for commercialization, and will develop comprehensive strategies to reduce costs, mitigate risks, and improve efficiencies.

RESPONSIBILITIES: • Hire, coach, and develop department leaders, and hold accountable for staffing, training, and developing the functional downstream leadership teams. • Evaluate effectiveness of measurement systems and performance indicators to include but not limited to skills matrix, scorecards, and KPIs for continuous improvement. • Responsible for developing overall department budget. Hold functional leaders accountable to meet or exceed individual expense budget expectations that include equipment, headcount, and new projects. • Ensures all products manufactured are produced, tested, and released in compliance with cGMP, SOP, FDA, and EU regulations. • Makes decisions regarding quality control and compliance for batches and for new and/or existing products, including discrepant batches (investigations, retesting, and re-inspections), and manages the review of compliance investigations. • Oversee procedures and specifications affecting product quality (e.g. batch records, SOP, validation protocols and reports) to ensure quality compliant products are released to market. • Supports inspections by FDA, EU, DEA, State and other regulatory agencies as secondary point of contact and partners with Regulatory to prepare inspection and observation responses. • Review and approve all facility and equipment changes that may affect cGMP.

QUALIFICATIONS AND REQUIREMENTS: • Bachelor’s degree in science or related field; Master’s degree preferred • 8+ years of experience in Quality Control or Quality Assurance in pharmaceutical manufacturing and 5+ years of experience leading Quality teams. Experience working with cGMP, DEA, USP, FDA, and EP agencies required. • 5+ years of experience in Quality Control or Quality Assurance in the animal health industry • Proficient with Microsoft Office Suite, including Word, Excel, PowerPoint, Outlook) • Experience with QMS and ERP Systems; Master Control preferred

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