The Manager, Regulatory & Clinical Affairs, plays a key role in ensuring regulatory compliance and labeling accuracy across all Quva sites. This role oversees third party submissions, supports product formulation, conducts therapeutic equivalency reviews, and manages the development of CSP and Bulk artwork. The Manager also coordinates investigations, supports customer onboarding through ASHP tool assessments, and partners with cross-functional teams to align regulatory and clinical activities with business goals, all while maintaining compliance with FDA 503B requirements. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement.
What the Manager, Regulatory & Clinical Affairs Does Each Day:
- Oversee third party submissions (First Data Bank, Medi-Span, Cerner Multum, IBM/Redbook)
- Review and approve the accuracy of label claims for new artwork creation and bulk labels to ensure alignment with FDA 503B labeling requirements
- Spearhead the development and regulatory oversight of CSP and bulk artwork across all QuVa sites to ensure consistency and compliance.
- Review and approve therapeutic equivalency for product conversion
- Drive team improvements by resolving inefficiencies and implementing sustainable, safety focused solutions
- Manage change requests for BUD extension in collaboration with Quality Control
- Review and approve REMS
- Support staff with pharmaceutical calculations, product formulations, and related labeling inquiries
- Serve as a backup for Master Batch Records, Bill of Materials as needed
- Strengthen team performance through workforce planning, development, and leadership growth initiatives
- Work with cross-functional teams to align Regulatory & Clinical Affairs activities with overall business objectives
- Coordinate investigations of deviations and CAPAs owned by Pharmacy Services
- Manage ASHP tool assessment questionnaires and support customer onboarding
- Collaborate on vendor contract questionnaires for new customers and renewals
- Evaluate Finished Drug Product to ensure label compatibility and compliance
- Assist with FDA inspections related to labeling and ensure compliance with 503B requirements
- Create and update SOPs as applicable
- Maintain a safe and clean working environment by complying with procedures, rules, and regulations
Our Most Successful Manager, Clinical & Regulatory Affairs has / is:
- Sense of urgency, accountability and resourcefulness (e.g., work in changing environment)
- Self-starter, independent learner
- Communication: Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
- Problem Solving: Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform
- Efficiency with MS Office suite
Minimum Requirements for this Role:
- Legally authorized to work in the job posting country
- Bachelor’s Degree required
- 5-7 years in an FDA cGMP environment with 3+ years in a supervisory role
- Quality or Pharmacy experience
- Knowledgeable in FDA cGMP compliance
- Must have hospital pharmacy experience
Benefits of Working at Quva:
- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 22 paid days off plus 8 paid holidays per year
- National, industry-leading high growth company with future career advancement opportunities
About Quva:
Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.
Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”
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Skills Required
- Licensed pharmacist
- 4+ years of experience in an FDA cGMP environment
- Quality or pharmacy experience
- Knowledge of FDA cGMP compliance
- Hospital pharmacy experience
- Strong verbal and written communication skills
- Problem-solving and process improvement ability
- Proficiency with Microsoft Office Suite
What We Do
QuVa Pharma is a leader in 503B outsourced compounding, serving all 50 states with a full portfolio of sterile, ready-to-administer injectable products. QuVa was purpose-built to change the 503B industry for the better and is leading the way in making it more safe, efficient, and reliable. With unmatched expertise in cGMPs and sterile pharmaceutical manufacturing, we achieve higher than required quality and safety standards and maintain a leading FDA compliance record, so hospitals can more confidently and reliably focus on patient care. While our leading cGMP processes, sterile-to-sterile portfolio, and expansive capacity of 300,000 sq ft across four facilities are the foundation of success, it is our transparency, customer-focused service, and contracted supply arrangements that enable us to help hospitals and health systems better meet their patient care and operational needs. As FDA compliance becomes more stringent, QuVa's ability to reliably supply the highest-quality products is more valuable than ever and allows hospitals to spend more time on patient care and less time worried about beyond use dates, waste, workload inefficiencies, and compliance. That is why QuVa is proud to be recognized as the partner of choice for many of the nation’s leading health systems. So, whether you are calling for a response or being called on for a solution, know that QuVa is accountable, and in us, you always have an answer.
