VP - Quality Systems

​​About the Role:

As the VP of Quality Systems you will play a crucial role in building leading integrating and managing quality system activities across all business units which includes R&D Compounding Dispensing and Fulfillment and Post Market Surveillance. This role will report to the SVP of Quality.

You Will:

• Management System (QMS) appropriate regulations and international and national regulations are aligned with regulatory agency expectations.

• Initiate and drive consistency of Quality Systems across compounding sites and corporate including but not limited to:  CAPAs Deviations Training Complaints Good Documentation Practice Data Integrity Supplier Quality etc.

• Develop and adapt the Management Review Process for Hims and Hers.

• Lead and document management review meetings. Oversee metrics and KPI’ s for evaluation and reporting to Top Management.

• Collaborate to identify appropriate IT systems to manage and house Quality Systems including document management

• Participate as part of the Hims and Hers Quality Leadership Team

• Develop strong relationships with Operations Product and Compounding site personnel.

• Develop and execute plans related to QMS improvements.

• Ensure compliance with regulatory requirements standards and BostonGene procedures/policies for all quality systems which include document control organizational and personnel change management corrective and preventive actions nonconformances deviation management audit program etc.

You Have:

• BS Degree in the Sciences or other technical discipline

• 15+ years of QA experience in the pharmaceutical industry or the equivalent combination of education experience and/or training.

• 8+ years managing a QA and/or Quality System department.

• Strong regulatory compliance knowledge including ISO FDA USP

• Experience with managing QA activities across multiple quality system requirements (e.g. operating under both ISO 9001 ISO 13485 ISO 14971 standards and FDA part 820 regulations).

• Proven track record leading and executing process improvements.

• Strong communication and presentation skills.

• Demonstrate ability to apply Root Cause Analysis tools and structured problem-solving methodologies to QMS issues.

• Effective organizational and time management and the ability to work toward multiple priorities while delivering quality outcomes.

• Certified Quality Auditor and/or Certified Quality Manager through ASQ is a plus

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.