Sr. Quality Specialist, QMS & Compliance

Piramal Pharma•Sellersville, PA

About The Position

The Senior Quality Specialist, QMS & Compliance is an experienced individual contributor responsible for the 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 and customer audits, supplier and service-provider qualification activities, and assigned 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. The role supports applicable FDA, DEA, EPA, OSHA and other safety, health, environmental and Quality requirements, policies and practices, while demonstrating the company’s mission, values and standards of ethical conduct. It also contributes to continuous improvement of the site Quality Management System, compliance, operational effectiveness and inspection readiness.

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.
Demonstrated ability to collect, analyze and interpret Quality data; identify compliance trends and improvement opportunities; and translate findings into metrics, dashboards, risk assessments and actionable recommendations.
Clear audit-report and compliance-record writing, ability to present objective evidence and host customers and auditors, and ability to coordinate cross-functional responses to 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.
Adhere to applicable FDA, DEA, EPA, OSHA and other safety, health, environmental and Quality requirements, policies and practices.

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, trackers, records and metrics, and escalate overdue activities or emerging compliance risks.
Plan, prepare and conduct risk-based internal audits and self-inspections across applicable functions; define scope, develop agendas and checklists, document objective evidence, issue observations and support timely closure.
Coordinate customer audits, including scheduling, readiness meetings, document requests, facility logistics, subject-matter expert preparation, audit-room activities, debriefs, observation tracking, response coordination and commitment closure.
Support FDA, DEA and other health-authority inspections, corporate audits and third-party assessments through readiness activities, document retrieval, front-room and back-room support, request tracking, evidence verification and response follow-up.
Coordinate audit-observation responses; assess findings for risk and systemic impact, track corrections, CAPAs and commitments, verify objective evidence, and support effectiveness checks before closure.
Analyze audit and compliance data to identify recurring observations, systemic vulnerabilities, risks and performance trends; maintain dashboards, prepare management-review reports, monitor corrective-action effectiveness and recommend improvement initiatives.
Analyze quality-system, audit, supplier, DEA, deviation, CAPA, change-control, training, complaint and other compliance data; develop metrics and trend reports, perform root-cause and risk-based evaluations, and partner with functional leaders on sustainable improvements.
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.
Plan and conduct remote and on-site supplier audits according to risk; prepare reports, communicate findings, evaluate supplier responses and CAPAs, track commitments and document closure recommendations.
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 risks.
Maintain supplier qualification files, approved-supplier status and supporting records; support the development, review and maintenance of supplier Quality Agreements.
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.
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 retrievable 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 supporting 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 associated with audit, supplier or DEA processes; apply root-cause analysis, risk assessment and sound documentation practices, and ensure actions are sustainable and completed on time.
Maintain accurate, controlled and retrievable records in approved electronic Quality and enterprise systems; follow ALCOA+ principles, access controls, audit-trail expectations and validated workflows.
Build effective working relationships with internal functions and customers, 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 and the incumbent’s training and qualifications.