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Director, Quality Systems

4 months ago

Sugar Land, United States QuVa Pharma Full time

Our Director, Quality Systems, 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 systems are compliant with the current Good Manufacturing Practices (21CFR210, 211) and 503B guidance documents.In partnership with the site leaders, sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Director, Quality Systems - Corporate is also responsible for:

  • The management of audit readiness and assisting with audit preparation, regulatory inspections, and customer audits
  • Managing the corporate quality documentation program including electronic batch records and managing the Documentation system master batch records creation and storage, off-site document storage, and records retention
  • The Director manages both site and corporate Change Control process, Quality Management Review, Critical Action Committees, CAPA program, and Quality Review Board meetings
  • The support of site and company-wide objectives through the reporting of department Key Performance Indicators
  • Coordination and working schedules of people and in the Quality Systems group
  • Ensuring people and processes comply with current Good Manufacturing Practices and company procedures
What the Director, Quality Systems - Corporate Does Each Day:
  • Manages the CAPA program (IR's, Deviations, and CAPA)
  • 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 to assess and improve the state of compliance of cGMPs
  • Modifies department standard operating procedures and executes change controls to support business and quality objectives
  • Manage Quality Standard program; Quality Council program; Critical Action Committee; Quality Review Board and Change Control program
  • Evaluates and tracks corrective action commitments resulting from internal audit, customer audit and agency inspection observations to verify implementation and effectiveness
  • Communicates compliance trends to Senior Management
  • Maintains control of the Quality Systems department budget and reports status to management as required
  • Provides leadership to the Quality System function, manages and provides development support to department personnel
Our Most Successful Director, Quality Systems - Corporate:
  • Has excellent written and verbal communication 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
  • Is well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP's and have demonstrated strength in problem solving and resolution
  • Prioritizes, handles and, tracks multiple assignments
  • Collaborates in a team environment
  • Is detail-oriented and task-focused outlook.
  • Possesses strong organizational and time management skills
  • Understands financial and accounting concepts
  • Maintains confidentiality, especially with handling sensitive documents and company information
Minimum Requirements for this Role:
  • Bachelor's degree in science or related field
  • 10+ years prior experience in a Quality/ cGMP / FDA regulated industry with 5+ years of supervisory or management experience
  • 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
  • Working knowledge of MS Office, especially Excel, Word, Outlook and PowerPoint
  • 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
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."