Sr. Quality Specialist, QMS & Compliance

Piramal Pharma Ltd•Sellersville, PA

About The Position

The Senior Quality Specialist, QMS & Compliance is an experienced individual contributor responsible for day-to-day execution and continuous improvement of site audit, supplier qualification, and DEA compliance programs in 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 specialist 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 role exercises independent Quality judgment within delegated authority and promptly escalates significant compliance, product, patient, customer, or business risks. The position requires adherence to applicable FDA, DEA, EPA, OSHA, safety, health, environmental, and Quality requirements, policies, and practices, as well as consistent support for Piramal Pharma Solutions’ mission, values, and ethical standards. The specialist performs other Quality Systems and Compliance activities as assigned by the Senior Manager, consistent with business needs, regulatory requirements, training, and qualifications. The work may involve frequent sitting, standing, and walking in office, laboratory, warehouse, and manufacturing areas; extended computer and document-review activities; and periodic travel to supplier or service-provider locations. Limited exposure to hazardous chemicals or controlled substances may occur in designated areas, and personal protective equipment may be required.

Requirements

Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Life Sciences, Engineering, Quality, or a related scientific or technical discipline.
At least seven years of progressively responsible experience in pharmaceutical, biotechnology, or other regulated life-sciences Quality Assurance, Quality Systems, compliance, or operations in a cGMP environment.
Demonstrated experience planning, conducting, documenting, and following up on internal, customer, supplier, or regulatory audits.
Experience with risk-based supplier qualification, supplier audits, approved supplier controls, periodic requalification, supplier corrective actions, and Quality Agreements.
Strong working knowledge of 21 CFR Parts 11, 210, and 211; applicable DEA requirements; ICH Q7, Q9, and Q10; and relevant cGMP expectations.
Experience with deviations, investigations, CAPA, change control, document control, training, risk management, metrics, and electronic Quality systems.
Ability to collect, analyze, and interpret Quality data; identify compliance trends, recurring issues, and improvement opportunities; and translate findings into metrics, dashboards, risk assessments, and actionable recommendations.
Ability to write clear audit reports and compliance records, present objective evidence, host customers and auditors, and coordinate cross-functional responses within defined timelines.
High attention to detail and 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 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 promptly escalate significant risks.
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.
Ability to perform the described work with reasonable accommodations where applicable; periodic supplier or service-provider travel may be required, and required PPE may include safety glasses, lab coats, gloves, specialized clothing, and appropriate footwear.

Nice To Haves

Lead-auditor experience or recognized auditor training.
Working knowledge of DEA controlled-substance requirements and experience supporting controlled-substance accountability, records, reconciliation, security, access controls, or inspection readiness.
Familiarity with EU GMP.
Experience in a pharmaceutical CDMO or complex, multi-product, multi-client manufacturing environment.
Experience with TrackWise, SAP, or MasterControl.
Experience using Microsoft Excel, Power BI, or comparable reporting and analytics tools.

Responsibilities

Execute the site audit program in alignment with the approved annual audit plan, risk priorities, procedures, and management direction; maintain schedules, records, trackers, and metrics, and escalate overdue activities or emerging risks.
Plan, prepare, and conduct risk-based internal audits and self-inspections across applicable Quality and operational functions; document objective evidence, issue observations, and support timely closure.
Coordinate customer and prospective-customer audits, including scheduling, readiness meetings, document requests, facility logistics, subject-matter expert preparation, audit-room activities, debriefs, observation tracking, responses, and commitment closure.
Support FDA, DEA, health-authority, corporate, and third-party audits through inspection-readiness activities, document retrieval, front-room and back-room support, request tracking, evidence verification, and response follow-up.
Coordinate risk assessment and responses to audit findings; track corrections, CAPAs, and commitments, verify objective evidence, and support effectiveness checks before closure.
Analyze audit data to identify recurring observations, systemic vulnerabilities, compliance risks, and performance trends; maintain dashboards and metrics, prepare management-review reports, and recommend improvement initiatives.
Analyze quality-system, audit, supplier, DEA, deviation, CAPA, change-control, training, complaint, and other compliance data; identify trends and risks, produce reports and dashboards, assess root causes and risk, and recommend and support sustainable improvements.
Manage lifecycle qualification of GMP suppliers, contractors, contract laboratories, and service providers, including risk classification, plans, questionnaires, document assessments, quality-history reviews, audit requirements, approval recommendations, requalification, and disqualification support.
Plan and conduct remote and on-site supplier audits based on risk; prepare reports, communicate findings, evaluate supplier responses and CAPAs, track commitments, and document closure recommendations.
Work with Procurement, Supply Chain, QC, Manufacturing, and technical functions to monitor supplier performance, investigate quality issues, support supplier corrective action requests, and escalate unacceptable risks.
Maintain supplier qualification files, approved-supplier status, and supporting records; support the development, review, and maintenance of supplier Quality Agreements.
Execute assigned DEA controlled-substance compliance activities, including records, accountability documentation, inventory reconciliation support, access authorization records, security checks, discrepancy assessment, reporting support, training, and inspection readiness.
Review controlled-substance transactions and inventory records for completeness, accuracy, and traceability; support inventories and reconciliations, investigate discrepancies with relevant stakeholders, and immediately escalate potential losses, diversion concerns, or reportable events.
Support maintenance of applicable DEA registrations, licenses, controlled-substance lists, and required records; maintain inspection evidence, participate in mock inspections, and support DEA inspections and follow-up commitments.
Author, revise, and periodically review SOPs, work instructions, audit tools, and training materials for audits, supplier qualification, and DEA compliance; deliver role-based training and monitor completion and effectiveness where assigned.
Initiate or support deviations, investigations, CAPAs, and change controls related to audit, supplier, or DEA processes, applying root-cause analysis, risk assessment, and sound documentation practices.
Maintain controlled, accurate, and retrievable records in approved electronic Quality and enterprise systems; follow ALCOA+ principles, access controls, audit-trail expectations, and validated workflows.
Build cross-functional relationships and lead or support improvements that strengthen compliance, reduce cycle time, improve right-first-time execution, and sustain inspection readiness.
Perform other Quality Systems and Compliance activities assigned by the Senior Manager, consistent with business needs, regulatory requirements, training, and qualifications.