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Manager, Technical Operations

Manager, Technical Operations

QuVa - Advancing Healthcare PossibilitiesBloomsbury, NJ, US
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Manager, Technical Operations

Our Manager, Technical Operations, plays a vital role within our organization. Once you complete our training, your responsibilities will include managing the process efficiency and / or remediation projects identified to support routine commercial demand targets for marketed products. This also includes management of Site development and execution of programs and processes designed to support Quva Pharma product introduction and continued process robustness as necessary to meet cGMP, DEA, regulatory, and company requirements. The primary function is developing strategic and creative solutions to production processes and company supply chain related efficiency targets against stretched company business objectives. This position will also support investigation of complex investigations and implementation of appropriate Corrective Action and Preventive Action measures identified to support resolution. 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. 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, Technical Operations Does Each Day :

  • Provides hands on oversight / execution of operational targets
  • Works directly with Director, Validation to meet New Product Introduction validation requirements targeted
  • Manages the daily commitment objectives from Corporate and Site Management organization as made available and works closely with peers in Operations, Pharmacy Services, Facilities Management, and Quality to assure processes conform to current standards for formulation and compounding operations in the most efficient manner possible
  • Leads teams of personnel dedicated to research, design, and execution of new processes or improvements to existing process to meet and commercialized product improvement objectives
  • Partners with Operations, Validation, Quality Assurance, and Pharmacy Services in the investigation of complex multi-faceted process deviations to implement CAPAs identified
  • Supports the development and execution of Quva policies, procedures, standards, and guidelines related to technical areas (Production, Processes, New Formulation Introduction, etc.)
  • Engages with Commercial Operations to ensure production processes are appropriately designed to ensure on-time supply of products to meet customer requirements
  • Provides Quality Partners, Commercial Operations, and Executive Management visibility of shop floor concerns related to production performance
  • Provides hands-on support in the phased introduction of process improvements required to meet Personnel and Material flow pattern objectives
  • Investigates and executes risk-based solutions deemed necessary to address business operational and compliance challenges related to production processes
  • Ensures effective communication and collaboration between Commercial Operations, Quality Compliance partners and operational shop floor personnel
  • Effectively identifies gaps in strategy and resources and resolves them
  • Ensures transparency of technical program actions / deliverables
  • Drives continuous improvement including introduction of automation and operational effectiveness to support the larger organization objectives of double-digit growth on the journey to #1 provider as 503B outsourcing facility
  • Provides monthly reports to upper management addressing key accomplishments, issues and drives improvement opportunities
  • Effectively arranges for work to be completed, schedules workflow and assignments to ensure delivery performance objectives for product or projects are met or exceeded
  • Drives Quality Management System assignments (CAPA, Deviation, Change Control, GMP tasks) to on-time closure

Our Most Successful Manager, Technical Operations :

  • Has a sense of urgency, accountability and resourcefulness (e.g., work in changing environment)
  • Has strong technical writing and verbal / written communication skills, including presentation skills
  • Demonstrates the ability to interact with people holding positions in manufacturing, both operations and quality including technicians, pharmacists, supervisors, area management, quality specialists as well as functional areas such as Human Resources, IT, Customer Service, Finance and Pharmacy Services
  • Develops action plans to meet a specific objective including identification and methods of tasks, milestones, resources requirements and metrics
  • Understands process flows, gap assessments and analysis of data to drive improvement
  • Is proficient in computerized tracking tools
  • Has comprehensive knowledge of adult learning techniques
  • Minimum Requirements for this Role :

  • Bachelor's Degree in Life Science or another related field (equivalent experience may be considered)
  • 5 years prior experience in cGMP / FDA regulated industry
  • 3 years of supervisory or management experience, or experience overseeing cross-functional project teams
  • Incumbent must possess strong analytical and problem-solving skills, extensive knowledge of GMPs, and ability to make decisions in a constantly changing environment
  • Hands-on direct shop floor involvement :
  • Troubleshooting
  • Problem solving
  • Process flow enhancements
  • Well versed in the compliance & quality requirements of 503B pharmaceutical industry and 21CFR 210 / 211 cGMP's
  • 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 :

  • Set, full-time, consistent work schedule
  • 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
  • Occasional weekend and overtime opportunities with advance notice
  • 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 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.

    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."

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