Director, Quality Assurance

QuVa Pharma; Bloomsbury (NJ); Sur place; USD 164 000 - 226 000; Plein temps

Avantages offerts par ce poste

Comprehensive health benefits

401k with company match

PTO + paid holidays

Career advancement opportunities

Résumé du poste

Quva Pharma in Bloomsbury, New Jersey is seeking a Director of Quality Assurance to lead QA and Quality Systems for sterile compounding operations, ensuring compliance with FDA 503B and cGMP. The role oversees QA/QS staff, directing release of batches and handling Deviations, CAPAs, and change controls with robust documentation.

This onsite leadership role requires strong technical writing, regulatory knowledge, and effective cross‑functional communication to maintain product quality and

Qualifications

• Bachelor's Degree in Life Science or 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.

Responsabilités

• 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 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.
• Maintains site documents supporting commercial manufacturing & release of sterile injectable products.
• Escalates to VP of Quality critical issues jeopardizing manufacturing & release of a safe & effective product.

Connaissances

Supervisory experience

Quality Assurance

cGMP knowledge

Regulatory compliance

Communication skills

Formation

Bachelor's Degree in Life Science or related field

Description du poste

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
• 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

Minimum Requirements for this Role:

• Education
• Experience
• 18+ years of ageAble 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

Benefits of Working at Quva:

• 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
• The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions
• Range: $163,764 - $225,881 Annually
• This role is also eligible for an annual incentive bonus, subject to program terms and guidelines

About Quva:

Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.

Equal Opportunity Employer

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".

California Consumer Privacy Act (CCPA) Notice for Applicants and Employees

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.