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.”
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
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