Director, Pharmacy

Quva • Bloomsbury, NJ

9h • $194,469 - $255,880

About The Position

The Director, Pharmacy is the primary clinical and regulatory authority for the facility, serving as the Pharmacist-in-Charge (PIC). This role is responsible for the strategic oversight of large-scale sterile compounding, ensuring that every batch meets the highest standards of safety, identity, strength, quality, and purity. You will bridge the gap between clinical pharmacy practice and industrial manufacturing, maintaining a state of continuous audit-readiness under 21 CFR Parts 210 and 211. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

Requirements

• S. in Pharmacy or Pharm D.
• 7-10 years’ experience in health-system pharmacy practice or a regulated pharmaceutical industry with 3+ years in a leadership capacity
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Knowledge of standard corporate business platforms including basic knowledge of Enterprise Resource Planning (ERP) systems used for ordering/supply, formulation/processing and operational work process flows
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Nice To Haves

• Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures
• Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics
• Pursues training and development opportunities; Strives to continuously build knowledge and skills
• Responds to requests for service and assistance; Meets commitments; Maintains confidentiality
• Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Inspires respect and trust
• Delegates work assignments: Gives authority to work independently; Sets expectations and monitors delegated activities
• Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness; Meets and exceeds requirements set forth in 21CFR210 and 211 for 503B Operation
• Works with integrity and ethical ability; Upholds organizational values
• Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments; Looks for ways to improve and promote quality; Monitors own work to ensure quality
• Observes safety and security procedures, Reports potentially unsafe conditions

Responsibilities

• Serve as the lead Pharmacist-in-Charge (PIC), maintaining full accountability for site compliance with State Board of Pharmacy, DEA, and FDA regulations
• Ensure that the manufacturing sites provide optimal pharmaceutical services that meet all legal, accreditation, and certification requirements
• Maintain records necessary to ensure accurate control over and accountability for all drugs as required by applicable state and federal laws, rules, and regulations; ensures legal operation of the compounding operation, including meeting all inspection and other requirements of state and federal laws, rules, and regulations governing the operation
• Evaluate and approve all Investigations, non-conformances, Deviations, and CAPAs, ensuring root cause analyses are robust to maintain patient safety
• Ensure appropriate controlled substance/DEA compliance, review documentation for accuracy and completeness, and determine outcomes associated with controlled substance investigations
• Oversee Compounding Operations, ensuring strict adherence to 21 CFR Parts 210 and 211 to maintain environment of continuous audit-readiness
• Authorize Master Batch Records, ensuring clinical formulation accuracy and alignment with validated processes
• Support new product development, partnering with business units to ensure safe and compliant compounding
• Provide clinical risk assessments as needed, evaluating impact to patient safety prior to disposition
• Provide leadership and oversight to Manufacturing staff, establishing standards for performance, training, and competency for formulation, compounding, packaging, and labeling
• Serve as clinical liaison for Manufacturing staff regarding, drug stability, compatibility, interactions, and therapeutic use
• Engage with customers to understand clinical needs and provide guidance for business development opportunities
• Obtain and maintain Pharmacist licensure in required states and serve as Designated Representative where required

Benefits

• Set, full-time, consistent work schedule
• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 25 paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National, industry-leading high growth company with future career advancement opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree