Director, Quality

 Published 19 days ago
    
 United States
    
 not provided
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​​About the Role:

Remotely based and reporting into the SVP of Pharmacy Safety, Quality and Compliance, the Director, Quality will be responsible for developing, implementing, evaluating, and maintaining the site Quality systems and leadership of the site’s Quality Assurance & Control systems.  They will ensure the organization’s internally compounded products meet the quality, integrity, and efficacy standards set by the organization.   They are a member of the site leadership who, in partnership with Operations leadership, will champion the creation of a Quality culture which embodies Quality by Design and Continuous Improvement expectations.  Directs all Quality aspects of the company’s compounding sites.  Interfaces with other leadership team members to help set policy and guide adherence to them as well as any applicable state and federal standards from boards of pharmacy, USP, and FDA.  Responsible for the decision on approval and release of all compounded products. Organizational responsibilities include site Quality Assurance, Quality Control documentation, and regulatory inspection activities.  Additional responsibilities include managing the Quality department budget, hiring and development of Quality personnel, performing employee appraisals/competency evaluations and management of the Quality organization.

You Will:

  • Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met. 
  • Provides expertise and guidance in interpreting USP and FDA regulations, agency guidelines and internal policies to assure compliance. 
  • Ensure quality system performance is measured and routinely reported to the executive management. 
  • Assist in escorting and providing information to regulatory officials during company audits/inspections.
  • Performs a variety of managerial tasks and duties to ensure the appropriate day to day operations of Quality Assurance, Quality Control, and Regulatory Affairs.
  • Ensures activities are completed within scheduled timeframes. (i.e. regulatory submissions/reports, CAPAs, investigations, ADRs, complaint closure, etc.)
  • Ensures adequate training (and documentation) of employees to SOPs, and Quality Assurance processes.
  • Collaborates in the design and implementation of new products. 
  • Ensures that products meet design specifications
  • Works closely with labs to ensure methods and analysis are appropriate for product label claims
  • Assist in the development of internal QC laboratory methods
  • Develop & negotiate Quality Agreements with new and existing direct material suppliers & vendors
  • Provide oversight for audits and visits to ensure 3rd party suppliers & vendors meet regulatory requirements
  • Manage relationships with 3rd party Quality vendors

You Have:

  • Bachelor’s degree or equivalent in Science or Engineering. 
  • Minimum 8 years experience in Quality Assurance; experience with cGMP preferred.
  • Experience working with pharmaceutical, and/or supplement manufacturers required. 
  • Must have experience with implementing new Quality Assurance and/or Control systems & processes in a high growth environment. 
  • Demonstrated experience directly managing teams, including cross functional people leadership; remote people leadership experience is a plus.
  • Experience working in a matrix organization
  • Willingness and ability to quickly come up to speed on quality requirements & regulations in new fields.
  • Comfortable working in a fluid environment, managing fluctuating priorities.
  • Demonstrated knowledge and understating of cGMP requirements and FDA regulations
  • Demonstrated knowledge and understanding of the Quality System Regulations (QSR), 21CFR Parts 210,211, 11, and 820 requirements and other related regulations with emphasis in CAPA Systems.
  • Strong communication skills with the ability to influence and drive internal & external decisions. 
  • Up to 35% travel

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.

 

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