Senior Quality Specialist - QMS & Compliance

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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 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 records. Follow ALCOA+ principles, appropriate access controls, audit-trail expectations and validated workflows.

Cross-Functional Partnership and Continuous Improvement: Build effective working relationships with Quality, Manufacturing, QC, Engineering, Validation, Warehouse, Supply Chain, Procurement, Security, Regulatory Affairs and customers. Lead or support improvements that strengthen compliance, reduce cycle time, improve right-first-time execution and sustain inspection readiness.

Additional Responsibilities: Perform other Quality Systems and Compliance activities assigned by the Senior Manager, consistent with business needs, regulatory requirements and the incumbent’s training and qualifications.

EDUCATION / EXPERIENCE

Education: Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Life Sciences, Engineering, Quality or a related scientific or technical discipline is required.

Industry Experience: Minimum seven (7) years of progressively responsible experience in pharmaceutical, biotechnology or other regulated life-sciences Quality Assurance, Quality Systems, compliance or operations in a cGMP environment.

Audit Experience: Demonstrated experience planning, conducting, documenting and following up on internal, customer, supplier or regulatory audits. Lead-auditor experience or recognized auditor training is preferred.

Supplier Quality Experience: Experience with risk-based supplier qualification, supplier audits, approved supplier controls, periodic requalification, supplier corrective actions and Quality Agreements is required.

DEA Knowledge: Working knowledge of DEA controlled-substance requirements and experience supporting controlled-substance accountability, records, reconciliation, security, access controls or inspection readiness is strongly preferred.

Regulatory Knowledge: Strong working knowledge of 21 CFR Parts 11, 210 and 211, applicable DEA requirements, ICH Q7, Q9 and Q10, and relevant cGMP expectations. Familiarity with EU GMP is preferred.

CDMO Experience: Experience in a pharmaceutical CDMO or complex, multi-product, multi-client manufacturing environment is preferred.

Quality Systems: Experience with deviations, investigations, CAPA, change control, document control, training, risk management, metrics and electronic Quality systems. Experience with TrackWise, SAP or MasterControl is preferred.

Quality Data Analytics and Trending: Demonstrated ability to collect, analyze and interpret Quality data; identify compliance trends, recurring issues and improvement opportunities; and translate findings into clear metrics, dashboards, risk assessments and actionable recommendations. Experience using Microsoft Excel, Power BI or comparable reporting and analytics tools is preferred.

Communication and Customer Interface: Demonstrated ability to write clear audit reports and compliance records, present objective evidence, host customers and auditors, and coordinate cross-functional responses under defined timelines.

JOB COMPETENCIES

High attention to detail and the ability to maintain complete, accurate and inspection-ready records.

Strong audit planning, interviewing, evidence evaluation, report writing and follow-up skills.

Ability to interpret regulatory and procedural requirements and apply them to practical, sustainable controls.

Sound investigation, analytical, problem-solving and risk-based decision-making capability.

Ability to synthesize data from multiple Quality systems, distinguish isolated events from systemic trends, and communicate actionable compliance insights to functional and site leadership.

Ability to manage multiple audits, supplier activities and compliance commitments with competing priorities.

Professional customer, supplier and regulatory presence with strong written, verbal and presentation skills.

Ability to exercise independent Quality judgment within delegated authority and escalate significant risks promptly.

Ability to influence cross-functional stakeholders without direct authority and hold owners accountable for timely execution.

Commitment to data integrity, ethical conduct, patient safety, product quality and a speak-up Quality culture.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions.

Frequent sitting, standing and walking throughout office, laboratory, warehouse and manufacturing areas may be expected.

This position may require extended periods of typing, computer entry, document review or viewing a computer screen.

Periodic travel to supplier or service-provider locations may be required based on audit and qualification needs.

Potential limited exposure to hazardous chemicals or controlled substances within designated work areas.

Personal protective equipment, including safety glasses, lab coats, gloves, specialized clothing and appropriate footwear, may be required.