Manager, Sterility Assurance

Our Manager, Sterility Assurance, plays a vital role within our organization. Once you complete our training, your responsibilities will include managing all the Quality Assurance and Quality Systems departments supporting all aspects of compounding sterile pharmaceuticals and regulatory compliance within the facility. This position will also operate within the legal and regulatory compliance, producing a quality product. Additional responsibilities include managing the QA and QS staff, coordinating roles, responsibilities, and projects. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.

What the Manager, Sterility Assurance Does Each Day:

• Manages QA & QS supervisors by providing learning and development where appropriate
• Makes 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
• Maintains 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 Manager, Sterility Assurance:

• Has strong oral and written communication ability, including presentation skills.
• Demonstrates interpersonal skills with the ability to interact effectively with individuals across manufacturing operations and quality roles, including compounders, pharmacists, supervisors, area management, quality specialists, and functional departments such as Human Resources, IT, Customer Service, Finance, and Pharmacy Services.
• Experienced in the development of action plans to meet specific objectives, including identifying tasks, setting milestones, determining resource requirements, and establishing metrics.
• Possesses successful time management skills to coordinate and ensure the accomplishment of approved action plans within established timelines and milestone tasks.
• Has a strong understanding of process flows, can conduct gap assessments, and analyze data to drive continuous improvement.
• Proficient with computerized tracking tools.
• Holds comprehensive knowledge of adult learning techniques.

Minimum Requirements for this Role:

• Bachelor's Degree in Life Science or another related field
• 5-7 years prior experience in a Quality/ cGMP / FDA regulated industry
• Minimum 5 years of supervisory or management experience required
• Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable products
• 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 people skills
• 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

Benefits of Working at QuVa:

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 22 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: $98,891 - $135,975 / Year
• 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.

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."