Director of Quality Assurance

24 hours ago

Brownsburg IN United States CS Recruiting Full time

Our client exists to strengthen healthcare supply chains. Their high-touch warehousing and distribution solutions reduce risk and increase efficiency for healthcare entities in the public and private sector.

Director of Quality Assurance
The Director of Quality Assurance is responsible for implementing and maintaining robust quality and regulatory systems which assures that products and services are reliable, safe, and effective. This includes maintaining cGMP, GDP and registrations across all Company businesses and vast knowledge of VAWD, FDA, and CFR standards.

Job Type: Full-time

Responsibilities:

  • Direct, mentor, train, and coach Quality and Regulatory teams and optimize organizational structure and staff.
  • Maintain Quality compliance and all regulatory reporting requirements through the development and oversight of appropriate strategies, tactics, and related activities.
  • Key contact between our client and all Regulatory agencies (FDA, DEA, VAWD, ISO).
  • Ensure regulated procedures are current, relevant, and properly followed.
  • Provide quality and regulatory functional oversight for client-specific needs and requests. Work with clients to anticipate and interpret client needs and business challenges.
  • Responsible for various elements of Quality Management Systems (i.e. Internal/External Audits, Document Control, Training, CAPA, Management Review, Validations, Regulatory registrations and submissions, and Annual product reviews as required).
  • Supports VP in development and monthly and annual balancing of the departmental budget through which all department activities and initiatives are funded.
  • Collaborate with the Operations leadership to complete all audit responses.
  • Assure calibrated warehouse environmental systems are current and maintained.
  • Ensure e-pedigree standards are maintained – DSCSA.
  • Responsible for our client’s 3rd party licensing services.
  • Help guide Operations team in determining the root cause of discrepancies and help develop corrective actions and verification activities.
  • Work with Quality Systems, policies and procedures, and all levels of facility personnel to achieve company quality standards and to ensure regulatory compliance.
  • Work closely with members of the Business Development team to acquire new clients.
  • Collaborate with commercial partners to ensure seamless execution of Quality Systems for products and processes throughout development, product launches, and commercialization phases.
  • Conduct gap analyses, benchmarking, gap assessments, and process improvement initiatives.
  • Other duties as assigned.

Experience:

  • Bachelor of Science (BS) degree in Engineering, Science, or a related field.
  • Minimum of 15 years in Quality Assurance with experience creating and implementing systems for Quality.
  • Minimum of 10 years of successful Quality managerial experience and ability to influence change.
  • Minimum of 10 years of Medical Device, Pharma, and Plasma experience preferred.
  • Extensive knowledge of analytical and quantitative aspects of Quality.
  • Experience with a third-party logistics provider.
  • Validation experience required.
  • Active member of ASQ, RAPs, or HDMA.
  • Deftly navigate through Quality and Warehouse Management Systems with training – ComplianceQuest, Tecsys Elite, WEBCTRL.
  • Intermediate Microsoft Office skills: Outlook, Excel (including Pivot Tables), PowerPoint.
  • Expert with FDA cGMPs per 21 CFR 210/211 and 820 and ISO 13485 standards.
  • Expert with FDA electronic submissions, new drug listings, and annual renewals.
  • Experience with DEA, VAWD, PDMA, DSCSA regulations.
  • Knowledge of state and federal laws and the ability to interpret and apply rules and regulations.
  • Advanced public speaking and presentation skills.
  • Ability to maintain and track budget/spending trends.
  • Excellent verbal and written communication skills.

This position offers a competitive base salary.

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