Quva Pharma Sugar Land , TX 77487
Posted 3 weeks ago
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
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
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."
Quva Pharma