Director, Quality Assurance
Leads the Quality Assurance and Quality Systems departments at QuVa Pharma's Bloomsbury, NJ site, which manufactures compounded sterile injectable pharmaceuticals. Oversees QA/QS staff, batch release, deviations, CAPAs, change controls, and environmental monitoring while maintaining FDA 503B and cGMP compliance.
- Compensation
- $163.8K–$225.9K / yr
- Location
- Bloomsbury, New Jersey, United States
- Work setup
- Onsite
- Seniority
- C level
- Employment
- Full time
- Experience
- 5+ years
- Category
- Qa
- Posted
Skills
Must have
- Bachelor's Degree in Life Science or other related field
- Minimum 10 years prior experience in Quality Assurance / cGMP / FDA regulated industry
- Minimum 5 years of supervisory or management experience
- Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable products
- 18+ years of age
- Able to successfully complete a drug and background check
- Currently authorized to work in the United States on a full-time basis (no visa sponsorship available)
Nice to have
- Technical writing and communication skills
- Well versed in compliance & quality requirements of 503B pharmaceutical industry and cGMPs, with strong problem-solving and resolution
- Strong interpersonal skills
- Strong oral and written communication ability, including presentation skills
- Ability to develop action plans including tasks, milestones, resource requirements and metrics
- Successful time management skills to coordinate accomplishment of approved action plans
- Understanding of process flows, gap assessments and analysis of data to drive improvement
- Proficiency with computerized tracking tools
- Comprehensive knowledge of adult learning techniques
Full description
The Director, Quality Assurance position is responsible for managing all Quality Assurance and Quality Systems departments supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility. This position operates within the legal and regulatory compliance, producing a quality product. This leader operates the area as the supervisor over the QA and QS staff, coordinating roles and responsibilities and projects. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement.
This is an onsite role located in Bloomsbury, New Jersey. What the Director, Quality Assurance Does Each Day:
- Supervises QA & QS managers by providing learning and development where appropriate
- Ability to make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations
- Manages the on-time release of batches
- Manages the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentation
- Manages others to ensure appropriate SOPs and training documents are in place & effective
- Manages others to ensure the design and maintenance of the environmental monitoring program including environmental and personnel monitoring are adequate and in place
- Manages others to ensure QuVa quality standards are met at the site so that processes are the same as other QuVa sites
- Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws
- Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities
- Manages others to maintain site documents supporting the commercial manufacturing & release of sterile injectable products
- Manages the design and implementation of site policies and procedures
- Escalates to VP of Quality critical issues jeopardizing manufacturing & release of a safe & effective product that meets regulatory requirements
- Promptly communicates with Operations regarding complaints, product issues/variances
- Enforces applicable personnel policies and procedures
Our Most Successful Director, Quality Assurance has / is:
- 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