Sr. Quality Specialist, QMS & Compliance

Job description

Be the First to Apply Division Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation. Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com Job Title Sr. Quality Specialist, QMS & ComplianceJob Description The Senior Quality Specialist, QMS & Compliance is an experienced individual contributor responsible for the day-to-day execution and continuous improvement of the site audit, supplier qualification and Drug Enforcement Administration (DEA) compliance programs within a pharmaceutical CDMO environment. Reporting to the Senior Manager, Quality Systems & Compliance, the role plans, coordinates, conducts and documents internal audits, customer audits, supplier and service-provider qualification activities, and assigned DEA controlled-substance compliance activities. The position partners with cross-functional process owners to ensure findings, commitments, corrective actions, qualification decisions and compliance records are accurate, risk-based, timely and inspection-ready. The incumbent exercises independent Quality judgment within delegated authority and promptly escalates significant compliance, product, patient, customer or business risks. Regulatory and corporate requirements: Adhere to applicable FDA, DEA, EPA, OSHA and other safety, health, environmental and Quality requirements, policies and practices. Values: Consistently support and demonstrate Piramal Pharma Solutions mission, values and standards of ethical conductKEY ACCOUNTABILITIES Audit Program Management: Execute the site audit program in alignment with the approved annual audit plan, risk priorities, procedures and management direction. Maintain schedules, trackers, records and metrics, and escalate overdue activities or emerging compliance risks. Internal Audits and Self-Inspections: Plan, prepare and conduct risk-based internal audits and self-inspections across Quality, Manufacturing, QC, Engineering, Validation, Warehousing, Supply Chain and other applicable functions. Define scope, develop agendas and checklists, document objective evidence, issue clear observations and support timely closure. Customer Audits: Manage audit scheduling, readiness meetings, document requests, facility logistics, subject-matter expert preparation, audit-room activities, daily debriefs, observation tracking, response coordination and commitment closure. Support quality operations project team with coordination of customer and prospective-customer audits. Regulatory and External Audit Support: Support FDA, DEA and other health-authority inspections, corporate audits and third-party assessments through inspection-readiness activities, document retrieval, front-room and back-room support, request tracking, evidence verification and response follow-up. Audit Findings, CAPA and Effectiveness: Coordinate responses to audit observations and ensure findings are accurately assessed for risk and systemic impact. Track assigned corrections, CAPAs and commitments to completion; verify objective evidence and support effectiveness checks before closure. Audit Trending and Reporting: Analyze internal, customer, supplier, regulatory and corporate audit data to identify recurring observations, systemic vulnerabilities, compliance risks and performance trends. Develop and maintain audit and compliance dashboards, prepare management review reports, monitor the effectiveness of corrective actions, and recommend targeted improvement initiatives to strengthen inspection readiness and overall Quality System effectiveness. Quality Data Analytics, Trending and Continuous Improvement: Analyze quality system, audit, supplier, DEA, deviation, CAPA, change control, training, complaint and other compliance data to identify adverse trends, emerging risks, recurring issues and systemic compliance gaps. Develop meaningful metrics, dashboards and periodic trend reports that provide actionable insights to Quality and site leadership. Perform root-cause and risk-based evaluations of identified trends, recommend corrective and preventive actions, and partner with functional leaders to implement sustainable improvements that enhance compliance, inspection readiness, operational effectiveness and overall Quality Management System performance. Supplier Qualification Management: Manage the lifecycle qualification of GMP suppliers, contractors, contract laboratories and service providers, including risk classification, qualification plans, questionnaires, document assessments, quality history review, audit requirements, approval recommendations, periodic requalification and disqualification support. Supplier Audits: Plan and conduct remote and on-site supplier audits based on material, service and compliance risk. Prepare reports, communicate findings, evaluate supplier responses and CAPAs, track commitments and document closure recommendations. Supplier Performance and Quality Issues: Partner with Procurement, Supply Chain, QC, Manufacturing and technical functions to monitor supplier performance, investigate material or service quality issues, support supplier corrective action requests, and escalate deteriorating performance or unacceptable compliance risk. Approved Supplier Records and Quality Agreements: Maintain accurate supplier qualification files, approved-supplier status and supporting records in applicable systems. Support the development, review and maintenance of supplier Quality Agreements and ensure responsibilities and change-notification requirements are defined. DEA Controlled-Substance Compliance: Execute assigned elements of the site DEA compliance program, including controlled-substance records, accountability documentation, inventory reconciliation support, access authorization records, security-control checks, discrepancy assessment, required reporting support, training and inspection readiness. DEA Records and Reconciliation: Review controlled-substance transactions and inventory records for completeness, accuracy and traceability. Support periodic inventories and reconciliations, investigate discrepancies with Security, Operations, Warehouse and other stakeholders, and escalate potential losses, diversion concerns or reportable events immediately. DEA Registration and Inspection Readiness: Support maintenance of applicable DEA registrations, licenses, controlled-substance lists and required records. Maintain readily retrievable inspection evidence, participate in mock inspections and support DEA inspections and follow-up commitments. Procedures, Training and Compliance Education: Author, revise and periodically review SOPs, work instructions, audit tools and training materials supporting audits, supplier qualification and DEA compliance. Deliver role-based training and monitor completion and effectiveness where assigned. Quality Events and Change Control: Initiate or support deviations, investigations, CAPAs and change controls associated with audit, supplier or DEA processes. Apply sound root-cause analysis, risk assessment and documentation practices, and ensure actions are sustainable and completed on time. Electronic Systems and Data Integrity: Use approved electronic Quality and enterprise systems to maintain controlled, accurate and retrievable reco