Our Director, Quality Compliance 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 overseeing quality compliance, developing risk assessment frameworks, and ensuring all QuVa Pharma facilities are compliant with the current Good Manufacturing Practices (21CFR210, 211).

The Director, Quality Compliance, is also responsible for:

• The support of site and company-wide objectives through the reporting of department Key Performance Indicators
• Ensuring people and processes comply 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
• Supporting audit readiness and assisting with audit preparation, regulatory inspections, and customer audits
• Supports a quality and compliance focused culture which embraces RFT and CI expectations in partnership with the site leaders

What the Director, Quality Compliance – Corporate Does Each Day:

• Maintains a working knowledge of government and industry quality assurance regulations and standards
• Establishes and maintains effective cross functional relationships
• Supports regulatory inspections and customer audits for each site
• Manages the corporate and site programs (i.e. self-improvement audits) to assess and improve the state of compliance of cGMPs
• Manage Quality Compliance program
• Supports Change Control & Corrective/Preventive Action commitments resulting from internal audit, customer audit and agency inspection observations to verify implementation and effectiveness
• Communicates compliance trends to leadership
• Maintains control of the Quality Compliance department budget and reports status to management as required
• Provides leadership to the Quality Compliance function, manages, and provides development support to department personnel
• Hires, leads and coaches quality compliance team

Our Most Successful Director, Quality Compliance – Corporate:

• Has outstanding written, oral communication skills
• Can organize large volumes of data
• Is experienced in pharmaceutical manufacturing especially sterile injectable
• Manages multiple, parallel projects
• Is an expert in regulatory requirements as they pertain to Human Drug Compounding and Pharmaceutical manufacturing

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
• Experience in Quality Assurance and Quality Control

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.”