Sr. Quality Specialist, QMS & Compliance

Piramal Pharma Limited; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Senior Quality Specialist, QMS & Compliance to lead and improve site audit activities, supplier qualification and DEA compliance within a CDMO. The role collaborates with process owners to ensure findings, corrective actions and compliance records are accurate and inspection-ready.

Reporting to the Senior Manager, Quality Systems & Compliance, the position emphasizes risk-based activities, regulatory adherence (FDA/DEA/OSHA), and continuous improvement

Qualifications

• Senior Quality Specialist responsible for day-to-day execution and continuous improvement of site audit, supplier qualification and DEA compliance programs within a pharmaceutical CDMO environment.
• Plans, coordinates, conducts and documents internal audits, customer audits, supplier qualification activities, and DEA compliance tasks.

Responsibilities

• Audit Program Management: manage the site audit program per annual plan and risk priorities.
• Internal Audits and Self-Inspections: plan and conduct risk-based audits across Quality, Manufacturing, QC, Engineering, and more.
• Customer Audits: schedule readiness, document requests, logistics, expert prep and closure.
• Regulatory Support: assist FDA, DEA inspections and third-party assessments with inspection-readiness.
• Audit Findings and CAPA: coordinate responses, track corrections and verify closure.
• Audit Trending and Reporting: analyze data, develop dashboards, report to management.
• Quality Data Analytics: analyze data to identify trends, implement preventive actions.

Job description

Division

Piramal Pharma Solutions Piramal 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 & Compliance Job 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 conduct

Key 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 elevate 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.