Senior Director, Quality Operations - Solid Dose

United Therapeutics Corporation • NC

88d

About The Position

The Senior Director of Quality Operations for Solid Dose leads site quality operations, including all aspects of cGMP manufacturing, packaging and distribution quality. This person drives lifecycle process quality in Manufacturing, Packaging, Distribution & CMOs, ensuring compliance with GMP requirements and timely disposition of products. This position reports to the SVP, Quality Operations. Responsible for med- to long-term goals and objectives for the QA and QC teams. Oversee, lead and drive the site Quality Operations function; represent function & responsible for strategic planning, direction, and achieving and communicating accountabilities and objectives to internal leadership. Build and maintain strong relationships with internal stakeholders and leaders across the organization. Drive the cooperative and collaborative working relationship with manufacturing site and CMOs and ensure established current and comprehensive Quality Agreements are in place and enforced. Ensure that the facility operations are in compliance with regulatory procedures and guidelines; accountable for the review and approval of all batch records, deviations and change control, validation and certification activities. Oversee and assist in the review and approvals of product packaging and labeling. Host Health Authority inspections and ensure overall audit readiness. Lead technology transfer projects; initiate special projects and support planning and execution. Work with Quality System group to complete risk management assessments; set future direction to improve product/process quality and work with other site quality leadership to maintain robust quality systems across the organization. Effectively create and promote continuous improvement efforts and support initiatives that improve United Therapeutics global quality. Charged with overall responsibility for planning, staffing, budgeting and managing expense priorities. Direct and manage direct reports to include responsibilities for training, goal setting & achievement, performance evaluations/management, coaching, mentoring, career development and provide support for recruitment process (as needed).

Requirements

• 15+ years of experience in quality aspects of the pharmaceutical industry with a Bachelor's Degree or 13+ years with a Master's Degree.
• 10+ years of people management experience.
• 10+ years of advanced working knowledge and experience with cGMPs and US FDA, EU and JP requirements.
• 5+ years of experience in management over both QA and QC functions.
• 5+ years of experience in small molecule drug analysis, sterile manufacturing or solid dose.
• 5+ years of experience in departmental budgeting.
• Advanced working knowledge of MS Office applications, including MS Word and Excel.
• Knowledge and experience in lab and manufacturing equipment qualification (IQ, OQ, PQ).
• Knowledge and experience in stability testing programs.
• Knowledge and experience in instrumentation experience and expertise in HPLC, GC, UV/VIS, FTIR.
• Knowledge and experience in FDA, USP and EP testing requirements.
• Detail oriented, self-motivated, organized, and able to prioritize work.
• Ability to work independently and as part of a multi-functional team.

Nice To Haves

• Master’s Degree in scientific discipline with equivalent experience/training.
• 10+ years of experience in analytical method development/validation and lab method transfer protocols.
• Working knowledge of TrackWise, MasterControl, SAP, Veeva.

Responsibilities

• Lead site quality operations for cGMP manufacturing, packaging, and distribution quality.
• Drive lifecycle process quality in Manufacturing, Packaging, Distribution & CMOs.
• Ensure compliance with GMP requirements and timely disposition of products.
• Oversee and drive the site Quality Operations function.
• Build and maintain strong relationships with internal stakeholders.
• Ensure compliance with regulatory procedures and guidelines.
• Review and approve all batch records, deviations, and change control.
• Host Health Authority inspections and ensure overall audit readiness.
• Lead technology transfer projects and support planning and execution.
• Complete risk management assessments and improve product/process quality.
• Promote continuous improvement efforts and support global quality initiatives.
• Manage planning, staffing, budgeting, and expense priorities.
• Direct and manage direct reports including training and performance evaluations.

Benefits

• Medical, dental, vision, and prescription coverage.
• Employee wellness resources.
• Savings plans (401k and ESPP).
• Paid time off & paid parental leave benefits.
• Disability benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees