Director, Quality Assurance

Quva • Bethlehem Township, NJ

6h • $163,764 - $225,881 • Onsite

About The Position

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.

Requirements

• 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
• Strong interpersonal skills
• Strong oral and written communication ability, including presentation skills
• Interpersonal skills demonstrating 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.
• Development of action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics.
• Successful Time management skills in order to coordinate successful accomplishment of an approved action plan with timelines and milestone tasks.
• Understanding of process flows, gap assessments and analysis of data to drive improvement
• Proficiency with computerized tracking tools
• Comprehensive knowledge of adult learning techniques
• 18+ years of age
• 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
• 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

Responsibilities

• 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

Benefits

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 20 PTO + 5 PLP paid days off plus 8 paid holidays per year
• National, industry-leading high growth company with future career advancement opportunities
• This role is also eligible for an annual incentive bonus, subject to program terms and guidelines

What This Job Offers

• Job Type: Full-time
• Career Level: Director