Senior Director, Quality Operations - Solid Dose

Senior Director Of Quality Operations For Solid Dose

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq : UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

You have a passion for leading high performing Quality teams and a knack for developing leaders around you but are still willing to "roll up your sleeves" and be hands-on whenever needed. 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)

For this role you will need

Minimum Requirements

15+ years of experience with progressive increases in responsibility in quality aspects of the pharmaceutical industry with a Bachelor's Degree or 13+ years of experience with progressive increases in responsibility in quality aspects of the pharmaceutical industry 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; 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 expertise with MS Word and Excel

Knowledge and experience in lab and manufacturing equipment qualification (IQ,OQ, PQ) protocol review, writing and application

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 have the ability to prioritize work

Must be able to work independently and as part of a multi-functional team, able to handle high workloads, stressful situations and deadlines

Preferred Qualifications

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

United Therapeutics requires this candidate to be 100% on-site at our Durham, NC location. Expected travel for this role is up to 50%

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.