Senior Director, Quality Operations - Solid Dose

California, US residents click here.

The job details are as follows:

Who We Are

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.

Who You Are

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<