Apply on Employer Site

Chiesi USA, Inc. · 2 days ago

Product Quality & CSV Manager

Cary, NC

Full-time

Hybrid

Senior Level

7+ years exp

Chiesi USA, Inc. is an international research-focused biopharmaceutical group committed to promoting a healthier world. The Product Quality & CSV Manager will ensure compliance with cGMP, CSV, and data integrity standards by providing quality oversight of validated GxP computerized systems and US product distribution.

BiotechnologyMedicalPharmaceutical

No H1B

Responsibilities

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

Qualification

Quality AssuranceComputer Systems ValidationUS federal regulationsMS OfficeSAPTrackwiseVeeva MedCommsVeeva PromoMatsCommunication skillsAttention to detail

Required

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