Senior QA Specialist - C&Q

This position is responsible for ensuring compliance with regulatory

and company policies following current Good Manufacturing Practices, Johnson & Johnson Policies and internal procedures through the following duties and

C&Q Lifecycle and Validation Program

· Represents Quality Assurance on qualification teams and provides QA oversight of C&Q and validation execution across the capital project lifecycle—user requirements, design review, construction, FAT/SAT, commissioning, qualification and handover—including leveraging commissioning (Good Engineering Practice) documentation into qualification per ASTM E2500 and the ISPE Baseline Guide Vol. 5 (2nd Ed.), in compliance with GMP, FDA, EMA and other regulatory requirements.

· Supports the development and maintenance of the site validation program, Validation Master Plan, and project C&Q and validation plans, ensuring alignment with regulatory and corporate

and with project timelines and deliverables.

· Participates in risk assessments (e.g., FMEA, HACCP, HAZOP, ICH Q9(R1) quality risk management, and CARA) for equipment, utilities and systems; performs QA review of system impact assessments and equipment/utility categorization; helps define critical aspects and critical design elements; and reviews

traceability matrices.

· Reviews and approves commissioning and qualification documentation, including User

Specifications (URS), FAT/SAT documentation, and Installation, Operational and Performance Qualification (IQ/OQ/PQ) protocols and reports, as well as validation protocols and reports (analytical, cleaning, process, sterilization, etc.).

· Ensures Good Documentation Practice and data integrity of vendor, EPCM and CQV contractor documentation leveraged as Good Engineering Practice evidence in qualification.

Aseptic Processing and Sterility Assurance

· Provides QA oversight of sterilization and decontamination qualification, including autoclave and SIP cycles, E-beam irradiation, and vaporized hydrogen peroxide (VHP) decontamination cycle development with biological indicators.

· Provides QA oversight of aseptic process simulations (media fills), sterile filtration and filter validation (including PUPSIT), cleanroom classification, airflow visualization (smoke) studies, and environmental monitoring performance qualification.

· Provides QA oversight of visual inspection qualification, including defect libraries and manual-versus-automated inspection comparison studies.

· Reviews and approves single-use system qualification, including evaluation of supplier documentation and extractables/leachables assessments.

· Supports development and implementation of the site Contamination Control Strategy (CCS) in alignment with EU GMP Annex 1.

Utilities, Facility and Operational Readiness

· Provides QA oversight of utility and facility qualification, including water for injection (WFI) and clean steam (including phased water system PQ), process gases, and HVAC.

· Reviews and approves temperature mapping of cold storage and controlled-temperature equipment and areas (e.g., refrigerators, freezers, cold rooms).

· Reviews turnover packages and manages QA disposition of punch-list items, discrepancies and qualification readiness prior to system handover.

· Supports QA set-up of the calibration and preventive maintenance programs, including onboarding of qualified assets.

Quality Systems, Licensure and Lifecycle

· Acts as the QA point of contact for deviations, CAPAs and change controls related to C&Q and validation activities.

· Supports process performance qualification (PPQ), pre-approval/pre-license inspection readiness, and the BLA/sBLA licensure path for the new facility.

· Reviews and approves Technology Transfer documents, ensuring they meet regulatory and J&J requirements.

· Supports the transition from C&Q into the ongoing validation lifecycle, including periodic review and requalification.

· Provides QA support and direction to project, engineering and C&Q teams on specific quality system elements to ensure business, quality and compliance goals are met following J&J Standards.

· Develops and implements C&Q and validation processes, procedures, forms, work instructions and tools in support of standing up the site quality management system and validation program.

· Collaborates with cross-functional teams (Operations, Engineering & Maintenance, Validation, Automation, MSAT, QC, etc.) and external partners (EPCM firms, CQV contractors and equipment vendors) to address quality issues and ensure compliance systems are implemented efficiently.

· Reviews and approves standard operating procedures (SOPs), work instructions