Job: Senior Vice President Quality

Title Senior Vice President Quality
Categories Quality
Location Lyndhurst, New Jersey

The Senior Vice President of Quality will provide executive leadership to establishing Quality Systems, Processes, Metrics and Quality Organization for the company that includes Quality oversight to the company’s China manufacturing facility. This also includes the management of all quality oversight activities related to both domestic and international CMOs. Accountability of the leadership position includes Quality Control, Quality Assurance and GMP/cGMP Compliance programs related to the manufacturing and packaging pharmaceutical products directly manufactured by Amerigen or by one of their approved CMO.

Reporting directly to the President and CEO of the company, this position is responsible to build a culture of quality within the company and as a role model provides guidance and coaching to all levels within the Quality organization and the leadership of the company. This includes establishing and maintaining policies, quality standards, procedures that will protect the company’s assets and meet minimum requirements of all relevant government agencies. This leader will establish a culture where the organization sees working with government agencies such as the FDA a learning opportunity and effective partnership. This position is a member of the Company’s senior leadership team.

Specific Responsibilities
  • Provides guidance and direction in the development and maintenance of quality systems for the Suzhou Amerigen operation
    in Suzhou China to assure compliance with FDA and CFDA regulations and cGMP requirements.
  • Ensures the development and maintenance of quality systems for the virtual operation
    in New Jersey for oversight of the various CMOs who manufacture product for Amerigen. This includes ensuring compliance with FDA and cGMP requirements.
  • Directs the external audit programs to ensure that the cGMP/GMP requirements are
    being achieved for all API, excipient, packaging suppliers, CMOs, Contract Service
    Providers, including contract laboratories.
  • Provides leadership and is accountable for the review and disposition of all products
    manufactured or packaged for the company by CMOs , including but not limited to the
    review and approval of all batch records, deviations and investigations.
  • Works closely with manufacturing leadership to provide quality support to manufacturing
    operations, product development and product registrations.
  • Provides oversight of outsourced complaint and PV services to assure compliance with
    all applicable regulations.
  • Accountable for the attraction and retention of talent including the ability to know how to
    build an affordable Quality organization talent pool, structure and process aligned with
    the company’s strategy.
  • Responsible to draft any required Quality agreements and manage the process related
    to Supplier APIs.
  • Undertakes projects as directed by CEO
Desired Skills & Experience
  • Graduate degree in Science. PhD a benefit.
  • Current head of Quality Control with Quality Assurance background
  • 15 years of Quality System Management experience with USA FDA inspections and regulations.
  • Strong background in both QC and QA.
  • Must have experience within the generic drug industry and knowledge of CFDA regulations.
  • Demonstrated experience in effectively leading a Quality Control organization within a manufacturing setting.
  • Demonstrated high intellectual horsepower and equal emotional intelligence.
  • Demonstrated ability to attract, retain and coach best talent.
  • Ability to have hands on attention to detail combined with the ability to step back and think strategically.
  • Track record of strong personal performance combined with demonstrated talent management and passion to participate and lead within a team environment.
  • Ability to manage and prioritize multiple activities and projects and demonstrate a leadership style that can marshal the organizations most important resources to the right outcome.
  • Demonstrated experience in strong risk assessment
  • Proficient in Quality Auditing and Supplier Qualifications programs, equipment, process, computer and cleaning validations, method development, transfer and validation, method development, transfer and validation, QC lab operations and data management, and GCPs. Must also be proficient with demonstrated knowledge of FDA/CFDA regulations, standards and guidelines.
  • MS office software proficient
  • Unwavering integrity, honest, straightforward
  • Quality mindset with a passion for excellence
  • Mentor/Coach
  • Team player with ability to operate independently and be a self starter. Knows what the ‘answer is’ and has ability to bring his/her organization to the right conclusion(s).
  • Strong operational and strategic vision acumen in a manufacturing setting.
  • Effective communication and interpersonal skills.
  • Trusted advisor who is resourceful and proactive with willingness to keep ego in check and roll up his/her sleeves as the situation requires to get the right result.
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