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Quality Manager

Quality Manager

PharmaviteNew Albany, OH, US
10 days ago
Job type
  • Full-time
Job description

Quality Manager

Help us bring the gift of health to life. Working at Pharmavite is an experience like no other. With a focus on complete nutrition for all, each endeavor is urgent and every day counts. You'll have the opportunity to work on the #1 selling national vitamin and supplement brand, Nature Made, as well as an exciting portfolio of other products that are shaping the future of the healthy living industry. Consumer-driven innovation, high quality products and a promising portfolio, all driven by a team with a shared sense of purpose that's Pharmavite. Join us to bring the gift of health to life.

This role is not available for sponsorship, including I-983 participation.

Position Summary :

The Quality Manager is responsible for all quality programs at New Albany and supports the oversight and continuous improvement of the quality procedures and systems, which enable site operations to deliver products that meet cGMP regulations, Pharmavite's high-quality standards, and our consumers' expectations.

The position leads the site Quality Control and Quality Assurance teams, with 5 direct reports and indirect responsibility for 25-30 employees. The Quality Manager is part of the New Albany site leadership team, with responsibility for assuring compliance with cGMPs, other regulations, company policies and procedures, including assuring site quality systems are maintained in a state of audit readiness.

Key Responsibilities :

Through startup :

  • As we ramp from start-up operations to full productivity, learn the Pharmavite quality systems and build the programs for the New Albany site. This includes method transfer, job instruction development, lab equipment qualification, and product qualification.
  • Hire and train Quality Control and Quality Assurance supervisory roles.
  • Work collaboratively with the site leadership team to build a quality-first mentality among all team members.

Ongoing production :

  • Ensure products are manufactured in a manner consistent with applicable cGMPs and meet all relevant quality standards, including the company's own quality standards.
  • Oversee sampling, inspection, and laboratory verification of raw materials, packaging components, labels, bulk products, and finished goods; as well as in-process inspection and final lot disposition (as applicable to the site's operations).
  • Provide strategic leadership to the organizational structure. Ensure organization provides proactive and strategically aligned talent life-cycle management : hiring, onboarding, initial and ongoing training & development, performance management, and succession planning. Develop capabilities (functional and managerial) to operate in diverse circumstances.
  • Create and foster a collaborative relationship with other areas (Operations, Planning, Maintenance, Finance, Distribution, etc.) within the manufacturing site.
  • Identify and assist in the continual management of quality improvement opportunities at the site, and if applicable, throughout the company. Align these improvement activities with organizational, site, and corporate strategic goals.
  • Ensure appropriate investigation processes are followed to identify root cause and appropriate corrective and preventive actions (CAPA) for quality issues, non-conformances, or deviations from written procedures.
  • Develop, review, revise, or approve controlled documents applicable to ensuring cGMP-compliant production of products, including standard operating procedures (SOPs), job instructions (JIs), master batch records (MBRs), specifications, and other quality documents.
  • Host all regulatory and certification audits. Lead the activities associated with any remediation actions if needed as a result of the site audit findings.
  • Ensure the organization is compliant with OJT and GMP training programs and documentation.
  • Ideal Candidate Profile :

  • The ideal candidate for this role is an experienced and proven leader with a deep appreciation for the operational requirements and technical challenges associated with manufacturing and laboratory operations in a cGMP-regulated facility.
  • They are process-focused, data-driven, have a passion for teamwork, and are champions of process excellence.
  • They are a visible leader who will partner and serve with their cross-functional peers to ensure the ongoing success of the New Albany site.
  • They are also a vital leader who can develop and implement a proactive vision for the quality team to support the site's production of Pharmavite's fast-growing gummy vitamin portfolio.
  • They are a proven leader who can engage with and develop their staff, and model Pharmavite's operating values of "Do The Right Thing", "Care Deeply and Do Something", "Run It Like You Own It", and "Discover, Learn and Apply".
  • You'll be most successful in this role if you have :

  • Demonstrated knowledge of cGMP requirements applicable to manufacturing and laboratory operations within the dietary supplement, pharmaceutical, food, or a similarly regulated industry.
  • Comprehensive knowledge of GMPs, SOPs, auditing, and inspection within the dietary supplement, pharmaceutical, food, or a similarly regulated industry.
  • A solid understanding of the analytical chemistry and microbiological test methods that are typical within the dietary supplement, pharmaceutical, food, or similarly regulated industry.
  • Strong communication and interpersonal skills, with the ability to interface well with employees at different levels within the organization.
  • Good critical thinking, deductive reasoning, and decision-making skills, with a data analysis and statistical aptitude.
  • To take on these challenges, you'll need to have :

  • A four-year college or university degree in Chemistry, Pharmacy, Biology, or related sciences. An advanced degree is preferred, or demonstrated technical leadership.
  • 5+ years of progressive leadership experience in the Quality organization of a dietary supplement, pharmaceutical, food, or closely related industry, primarily leading teams that include quality control and quality assurance. Direct analytical chemistry experience is strongly preferred.
  • ASQ and / or Six Sigma / Lean certification with continuous process improvement experience is preferred.
  • Our Offer :

    Here, career paths aren't predefined, and bureaucratic limitations don't exist you have the opportunity to grow, learn from industry pioneers, and develop the way you want to. Pharmavite is investing more in the development of our team to help us deliver on our purpose and help you achieve your career aspirations. Our environment is geared to fuel curiosity, encourage experimentation, and generate learning as this is the way we develop ourselves and our organization. Pharmavite is committed to meeting the needs of our employees and their families with a Total Rewards package that's as comprehensive as the vitamins and supplements we deliver to consumers. With competitive compensation programs and standout benefits, we provide employees with optimal health and well-being as well as peace of mind. These rewards plus our new recognition program ensure employees feel supported both at work and home.

    National Target Base Pay Range : $112,000.00 - $190,000.00. The salary range for this position is based on national standards. For candidates in California and the New York metro, the Target Base Pay Range is $124,000.00 - $212,000.00, to reflect the cost of living and market conditions in those areas.

    Actual compensation will take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location, education, experience, qualifications, and job-related skills. It is not typical for an individual to be hired above the midpoint of the range for their role, and compensation decisions depend on the facts and circumstances of each case. This information is provided to applicants in accordance with state and local laws.

    Base pay is only one component of our total rewards offerings, and we will take the full offering into consideration when presenting an offer of employment. Our total rewards package for this position may also include an annual performance bonus, Medical, dental, and vision benefits, 401K match, and other wellness benefits.

    Pharmavite is an equal opportunity employer. We prohibit employment discrimination and harassment based on race, color, religion, age, sex, sexual orientation, gender, national origin, and any other basis protected by state and federal law. Pharmavite recruits, hires, employs, trains, promotes, and compensates individuals solely based on job-related qualifications and abilities.

    Pharmavite also provides reasonable accommodation to qualified individuals with disabilities or based on a sincerely held religious belief, in accordance with applicable laws. If you need to inquire about an accommodation to complete the application process, please email recruiter@pharmavite.com.

    Disclaimer : The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications of employees assigned to this job.

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