Director of Quality Operations

The Director, Quality Operations will direct quality assurance (QA) oversight of drug substance and drug product release, review and approval of quality event investigations at external manufacturing partners, and coordination of release activities with partners. Manage the execution of defined processes that confirm the quality of manufactured products are in compliance with all applicable regulations and guidance.

Compensation $180,000-$200,000 a year plus bonus.

Qualifications

• Lead the Quality Operations group primarily responsible for providing quality oversight and support to the
• Facility operations in the following key areas/activities; support of manufacturing operations across all phases of commercial production, support of QC laboratory operations, and material management including engineering, validation/qualification, and facilities/utilities.
• Overall responsibility for the management of the Product Release department which includes managing the staff by providing guidance, training, and coaching.
• Oversees the review process of batch records and testing documents confirming compliance with approved practices and procedures. Ensures documentation suitability against regulatory standards.
• Oversees release of raw materials, intermediate and final product confirming compliance with SOPs, regulatory guidelines, commitments to regulatory agencies, and BLA filings.
• Provide oversight and guidance to external manufacturing partners with respect to lot release activities, OOS investigations, scheduling priorities, and final disposition.
• Oversees conduct of investigations resulting from process deviations, out of specification results, and adverse data trends. Facilitates, participates, reviews, leads and/or approves Investigations, and root cause analysis.
• Further develops key quality processes, metrics and indicators to measure, trend and improve key quality determinants with respect to product release operations.
• Collaborate closely with Quality Control and Supply Chain on lot release activities and develop systems and processes that increase compliance and efficiency.
• Communicate lot disposition pending issues to VP, Quality.
• Lead quality issue escalation activities, as required.
• Interface with Sr. Management and responsible individuals to assure task completion on or before established due dates.
• Function as the Quality department liaison and subject matter expert to other department representatives, external partners and regulatory representatives.
• Recruit talent and build a high-performance team; mentors and coaches colleagues.

Education Requirements:

Bachelor’s/Master’s degree in science or related technical field.

Experience Requirements:

Minimum of 12 years experience in the pharmaceutical or biotechnology industry;

8+ years of leadership experience in quality assurance.

In addition to competitive compensation, we offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free shuttle to the Boca Tri-Rail station