Product Quality, CSV Manager
Chiesi Group
full-time
Posted on:
Location Type: Hybrid
Location: Cary • North Carolina • United States
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About the role
- 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, TrackWise, 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
Requirements
- 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 audit systems against all applicable regulations
- Proficiency in reading, interpreting, and evaluating CFR, regulatory guidance, company policy and procedures
- Demonstrated proficiency in Written, Verbal and Face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global), and government agencies
- Ability to successfully manage multiple tasks and multifunctional resources concurrently while maintaining high attention to detail while responding to rapidly changing priorities and aggressive deadlines
- Proficient in MS Office (Word, Excel, Project, MS Outlook), Adobe, Trackwise, SAP and EDMS
- Veeva MedComms or Veeva PromoMats experience preferred
Benefits
- Comprehensive healthcare programs
- Work-life balance initiatives
- Robust relocation support
- Flexible working arrangements
- Remote work options
- Tax assistance services for foreign colleagues
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Computer Systems ValidationQuality AssuranceChange ManagementRisk AssessmentValidation PlanningProtocol ReviewDeviation ManagementData IntegrityRegulatory ComplianceBatch Documentation Review
Soft skills
CommunicationAttention to DetailProject ManagementInfluencing Decision MakingRelationship BuildingProblem SolvingFeedback ProvisionMultitaskingAdaptabilityCollaboration