Director, Quality Validation - Corporate

Our Director, Quality Validation, plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include ensuring site and corporate Quality Validation and Qualification are compliant with the current Good Manufacturing Practices (21CFR210, 211). This includes validation and/or qualification of manufacturing facilities, equipment, processes, technical transfers, test methods, formulations, stability studies, software, etc. that establish the safety, efficacy, and compliance of QuVa’s compounded sterile preparations.

Director, Quality Validation – Corporate Is Also Responsible For

• Supporting audit readiness and assisting with audit preparation, regulatory inspections, and customer audits
• Supporting a quality and compliance focused culture which embraces RFT (right first time) and CI (continuous improvement) expectations in partnership with site leaders.
• Development of SOPs and policies instituting the requirements for validation and qualification
• Approval of validation and qualification protocols, deviations, and reports
• Supporting both site and corporate Change Control processes with respect to validation and qualification
  
  

What The Director, Quality Validation – Corporate Does Each Day

• Supporting site and company-wide objectives through the reporting of department Key Performance Indicators (KPI)
• Manages the Quality Validation Department budget and development of personnel
• Responsible for coordination and working schedules of people and in the Quality Validation group
• Responsible for people and processes compliance with current Good Manufacturing Practices and company procedures
• Modifies department standard operating procedures and executes change controls to support business and quality objectives
• Establishes and maintains cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Pharmacy Services, Research & Development, and Supply Chain to meet site and corporate objectives
• Maintains a working knowledge of government and industry quality assurance regulations and standards
• Supports regulatory inspections and customer audits for each site
• Manages the corporate and site programs to assess and improve the state of compliance of cGMPs
• Manages Quality Validation and Quality Qualification program
• Supports Change Control that are associated with validation and qualification
• Supports corrective action commitments resulting from internal audit, customer audit and agency inspection observations to verify implementation and effectiveness
• Communicates compliance trends to leadership
• Provides leadership to the Quality Validation function, manages and provides development support to department personnel
  
  

Our Most Successful Director, Quality Validation – Corporate

• Has strong oral and written communication ability, including presentation skills
• Demonstrates the ability to interact with people holding positions in manufacturing, both operations and quality including compounders, pharmacist, supervisors, area management, quality specialist as well as functional areas such as Human Resources, IT, Customer Service, Finance and Pharmacy Services
• Develops action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics
• Coordinates successful accomplishment of an approved action plan with timelines and milestone tasks through organizational and time management skills
• Understands process flows, gap assessments and the analysis of data to drive improvement
• Is proficient with computerized tracking tools
  
  

Minimum Requirements For This Role

• Bachelor’s degree in science or related field
• 10+ years of experience in manufacturing operations in pharmaceutical (cGMP / FDA regulated) industry with 5+ years in a supervisory role
• Technical writing and communication
• Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
• 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
  
  

Any Of The Following Will Give You An Edge

• Has experience with manufacturing of parenteral product
• Comprehensive knowledge of adult learning techniques
  
  

Benefits Of Working At QuVa

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• A minimum of 25 paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities
  
  

About QuVa

QuVa Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.

As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.

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.”