Product Quality & CSV Manager

Chiesi USA

Based in Parma, Italy, Chiesi is an international research-focused biopharmaceutical group with 90 years' experience, operating in 31 countries. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas.

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At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.

Diversity, inclusion, and equal opportunity are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.

This position ensures Chiesi USA, Inc.'s compliance with cGMP, CSV, and data integrity standards by providing quality oversight of validated GxP computerized systems and US product distribution, including batch release, labeling, artwork approvals, and related quality system responsibilities. Candidates must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.

• Provide quality oversight of validated GxP computer systems supporting product US marketed products:
  • Provide quality presence and input to technical meetings with internal teams and third parties, including discussions related to system validation, data integrity, and system lifecycle management.
  • Support and participate in CSV lifecycle activities for GxP systems (e.g., SAP, Track Wise, Veeva, etc.) including risk assessments, validation planning, protocol review/approval, deviation management, periodic review, change controls, and system retirement activities.
• Establish strong working relationships with clear communication, defined actions, and goals across Quality, IT, Business System Owners, and external partners.
• Provide quality oversight on Chiesi USA, Inc. commercial product(s) as a product owner supporting product quality release and distribution:
  • Review batch documentation and/or shipping documentation for disposition of product for the US market with little to no Manager assistance.
  • Review and approve product-related documents (e.g., validation protocols, stability protocols, batch records, etc.), with little to no Manager assistance.
  • Provide direct support of product-related activities including validation, technical transfers, supplier qualifications, stability, vendor audits, product complaints and temperature excursions with CMOs and internal stakeholders.
  • Actively review and provide productive feedback to CMOs on all critical quality issues (investigations, deviations, APRs, stability results, CAPAs, validation activities, including CSV-related deliverables).
  • Ensure all aspects of the distribution of pharmaceutical products are compliant with Quality Agreements, applicable cGMP regulations, and internal SOPs.
  • Support internal and external audits and inspections as needed.
• Provide quality assessment and oversight of internal and external Change Controls, including evaluation of impact to validated computerized systems:
  • Manage change controls for assigned products and systems, including timely review, risk assessment, approval, and closure.
  • Assess change controls for potential impact to validated state, data integrity, and regulatory compliance, and ensure appropriate CSV activities are defined and executed.
  • Communicate with CMOs, IT, Business System Owners, and internal functional areas regarding change controls affecting products and GxP systems.
• Ensure compliance with applicable government agency requirements:
  • Assist with FDA inspections and regulatory audits
  • Remain current with FDA/CFR requirements, guidance documents, and industry best practices related to cGMPs, CSV, and data integrity.

• BS/BA in Chemistry, Pharmaceutical Science, or Biologic Science from an accredited university or equivalent experience.
• Quality Assurance experience in the pharmaceutical industry: 7+ years.
• Computer Systems Validation experience in the pharmaceutical industry: minimum of 3 years.
• Ability to propose, evaluate, approve, implement and review changes processed within the Quality System in addition to developing new processes into the company Quality System.
• Experience reviewing, and/or approving validation protocols and reports as well as reviewing changes against validated parameters as required in the regulatory application.
• Comprehensive understanding of US federal regulations and processes, specifically related to change management and validation, and the ability to…