Senior Specialist, Quality Assurance

Position Overview The Sr. Specialist Digital & Data Quality is responsible for quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations. Essential Functions and Responsibilities Collaborate with stakeholders (system/process/data owners, business units, technical units, SMEs) to assess/remediate legacy systems and evaluate/implement new computerized systems enabling GxP business processes. Ensure technologies meet business needs while encouraging innovation and efficiency. Interface with Corporate Global IT and internal/external entities to align GxP technology capabilities/solutions with quality policies and objectives. Ensure project tailoring matches complexity and risk. Provide independent quality approval of key qualification/validation documentation (policies, procedures, acceptance criteria, plans, protocols, specifications, reports, and computerized system changes) to ensure compliance throughout the system lifecycle. Ensure system owners maintain operating level procedures/plans to keep computerized systems validated (e.g., problem/incident management, change control, periodic review, investigations, backup/restore, user data review/audit trail review instructions, disaster recovery, business continuity). Review processes and evidence that computerized-system compliance activities are in place and effective. Support regulatory inspections/audits; review audit/inspection reports and respond to findings. Drive resolution of regulatory non-conformance for GxP computerized systems. Communicate system health/compliance metrics; promote GxP awareness and continuous improvement. Represent Digital & Data Quality management in local/system meetings. Develop/maintain training programs on computerized systems validation, software assurance, regulatory requirements, data integrity (ALCOA), and use/maintenance. Provide Quality Unit review/approval of SDLC documentation. Mentor and guide junior team members. Qualifications Bachelor’s degree (preferably Science, Information Technology, Engineering, or equivalent). Experience Hands-on experience supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations. Minimum 5 years in regulated pharmaceutical manufacturing industry. At least 3 years delivering validated IT solutions or application support in a regulated environment. Strong knowledge of FDA/EU/ICH regulations, emphasizing 21 CFR Part 11, 210, 211, and 820. Extensive knowledge of computerized system validation/compliance. Experience implementing quality systems in pharmaceutical/lab/biotechnology environments. Preferred Competencies/Skills Professional certifications (e.g., Six Sigma, PMP). Self‑directed, priority‑setting; collaboration with technical and non‑technical roles. GMP quality/compliance experience; regulatory inspection leadership. Excellent communication, analytical problem solving, timely decision‑making, adaptability. Required Skills Adaptability; cGMP regulations; change controls/management; CSV; data integrity; deviation management; Emerson DeltaV; GAMP; MES; periodic reviews; pharmaceutical quality assurance; quality auditing; QMS/quality standards; regulatory compliance; requirements specification; RTM; risk management; SOPs; system validation. #J-18808-Ljbffr Scorpion Therapeutics