Manager, Site Quality Systems

Our Manager, Site 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 managing Quality System aspects of compounding pharmaceuticals for compliance within the facility. This position operates as the supervisor for designated Quality Systems staff, coordinating day-to-day functions. 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 Manager, Site Quality Systems Does Each Day:

• Manages, develops, and leads 2-5 Quality System Specialists
• Manages the internal audit and inspection readiness programs for site including coordination of regulatory (FDA) audits, and customer audits
• Responsible for all activities related to the Batch Record Issuance/ Quality Document Administration/CAPA/Deviation/Investigation/Change Management Systems
• Manages investigation/deviation activities by working with other departments to determine the possible causes of the deviation. Aids in the analysis of each of the possible causes in order to determine the true root cause. Coordinates follow up on due dates and status reports and closure
• Provides review of investigation reports and supportive documentation (including data) for accuracy and completeness, where needed
• Maintains the CAPA System and Change Management System, following up on due dates and status reports and closure with appropriate documentation
• Proposes and executes process and procedural changes to improve QS process performance, robustness, and efficiency
• Establishes standard and meaningful metrics that align to goals, mission, and objectives for applicable department/program. Develops and distributes metrics to support the business
• Facilitates site Quality Review and Management Review Board meetings
• Collaborates functionally and cross-functionally to meet Quality Systems objectives and initiatives
• Interacts with site efforts to ensure consistency in policies and practices

Our Most Successful Manager, Site Quality Systems:

• Have strong technical writing and verbal/written communication skills
• Develop action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics
• Possess time management skills

Minimum Requirements for this Role:

• Bachelor’s Degree in Life Science or another related field required
• 5 years prior experience in Quality Assurance /Laboratory/ cGMP / FDA regulated industry
• Minimum 2-5 years’ supervisory experience
• Well versed in the compliance & quality requirements of 503B pharmaceutical industry and CGMP’s and have demonstrated strength in problem solving and resolution
• 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:

• Leadership experience
• Excellent technical writing and verbal/written communication skills
• Strong interpersonal skills

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

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.”