Director - Quality Program Management (PMO)

​​About the Role:

The Director, Quality Program Management sits on the Compounding PMO, reporting to the Director of Program Management, and is responsible for supporting The Global Head of Quality across all 503a & 503b compounding programs. This is a director level project management role that will individually manage quality initiatives as well as lead a growing team of Quality Program Managers.

The goal of this role is to anticipate, mitigate, and navigate risk, maintain clear internal communication across all related teams company-wide, and keep all teams moving forward and in sync. This role will require a combination of exceptional people and project management skills, highly technical knowledge of regulatory and quality requirements, and confident dexterity in navigating a dynamic and growing organization. The scope of this role will be broad and adaptive to support our teams and facilities as they grow. 

This role will be responsible for managing teams remotely as well as on-site. This role is a remote role with regular travel (up to 50% of the time) to our facilities located in Ohio, Arizona, and California.

You Will:

• Build and manage a growing team of Quality Project and Program Managers that are responsible for managing 503a and 503b sterile and non-sterile pharmaceutical compounding programs

• Directly support the SVP, Global Quality and Quality, Safety, and Compliance team’s needs and objectives, including developing & driving forward key performance indicators of success of the department and its employees.

• Develop and execute a Quality Initiatives roadmap for our 503a & 503b facilities in Arizona and Ohio, aligning departmental objectives with the company's overall goals.

• Develop schedules for projects of varying sizes and scopes including preventative maintenance, major projects, and facility modifications. Coordinates shutdowns with operational management to ensure the availability of resources for timely completion to maximize manufacturing capability, as needed.

• Collaborate closely with cross-functional teams, including Operations, Pharmacy, and other functional areas to ensure synergy and alignment in supporting the manufacturing process.

• Manage day-to-day activities of the roadmap and all assigned projects, ensuring the team has clear directives and meets critical deliverables and timelines

• Show agility by adapting projects as they develop and change in order to meet the technical challenges in compliance with current Good Manufacturing Practice guidelines.

• Utilize your in-depth experience with Quality Management Systems, including Change Controls, corrective and preventive actions to drive the highest quality standards across the organization.

• Drive process definition for a growing team, including implementing new tools and technologies to support streamlined & efficient processes.

• Drive accountability across the organization to complete programs and initiatives on time.

• Inform and escalate to the SVP, Global Quality on a regular basis in a clear and concise format.

• Drive continuous improvement by managing projects and recommending techniques to enhance equipment, system, and process robustness and maintain the facility in peak condition.

• This role will be responsible for managing teams remotely as well as on-site. This is a remote role with regular travel (50% of the time) to our compounding pharmacies located in Los Alamitos, CA; Gilbert, AZ; and Columbus, OH.

You Have:

• 12+ years of project management experience in the Pharmaceutical industry

• 8+ years of project management in 503a and/or 503b Pharmaceutical Compounding

• 8+ years experience managing a team

• Masters Degree or Doctorate in Health Administration, Pharmaceutical Sciences, Quality Assurance/Control, Chemistry, Biotechnology, or Public Health

• Experience operating within product-driven organizations with many stakeholders and with fast-moving programs

• Excellent verbal and written communication skills

• Experience managing various stakeholders and being flexible to different working styles

• Extreme attention to detail and documentation

• Strong leadership and relationship-building skills with an ability to quickly make decisions while remaining objective

• Can-do, positive attitude that enjoys managing multiple projects and tasks simultaneously

• Curious and collaborative mindset with the ability to foster teamwork at all levels of the organization

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles

• Unlimited PTO, company holidays, and quarterly mental health days

• Comprehensive health benefits including medical, dental & vision, and parental leave

• Employee Stock Purchase Program (ESPP)

• Employee discounts on hims & hers & Apostrophe online products

• 401k benefits with employer matching contribution

• Offsite team retreats

Conditions of Employment: 

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.

• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).

• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.

• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.