Specialist, Quality & Compliance

Specialist, Quality & Compliance

Job Summary

The Specialist, Quality & Compliancewill be responsible toensure regulatory complianceacross all aspects of the PET business, including manufacturing, clinical trials, marketing, and distribution of JDR manufactured products. They are also responsible for ensuring that all data generated and maintained within the organization complies with regulatory requirements, internal policies, and industry best practices. This role plays a critical part in maintaining the integrity, accuracy, and reliability of data used in pharmaceutical development, manufacturing, and quality control.

Key Responsibilities

• Regulatory Monitoring and Interpretation
  • Stays updated on regulations from agencies like the FDA
  • Interprets how these regulations apply to the company's operations.
  • Conducts gap assessments to assess compliance in regard to FDA regulations impacting cGMP operations, as well as for updates in new Regulatory requirements.
• Policy Development and Implementation
  • Develops and maintain internal compliance policies and procedures.
  • Ensures these policies align with current laws and industry standards.
• Quality System
  • Oversees systems like document control, CAPA (Corrective and Preventive Actions), change control, training, deviation management, and complaints.
  • Ensures these systems are functioning effectively and are continuously improved.
  • Assists in the investigation and resolution of non-conformances, deviations, and CAPAs.
  • Monitors and reports on quality system metrics and key performance indicators (KPIs).
• Audits and Inspections
  • Conducts internal audits to assess compliance.
  • Prepares for and support external regulatory inspections.
• Risk Management
  • Identifies potential compliance risks and recommend corrective actions.
  • Investigates compliance breaches and report findings to senior management.
• Training and Education
  • Trains employees on quality & compliance topics
  • Serves as the Subject Matter Expert (SME) for the quality & compliance activities being responsible for providing guidance, training, and support to ensure adherence to JDR procedures and regulatory standards.
• Documentation and Reporting
  • Files and archives GMP documents in compliance with the record retention schedule and archiving requirements.
  • Ensures the ongoing improvement of established procedures and adherence to systems and processes.
  • Administers, coordinates and executes the review, the implementation and distribution of any controlled documents.
  • Reviews and approves specifications as well as stability protocols and reports
  • Ensures documentation is audit-ready and supports regulatory submissions.
  • Reviews and approves validation documentation for equipment, facilities, CSV, systems, instruments, analytical method and cleaning.
• Supplier Management and Oversight
  • Serves as the primary liaison between the company and suppliers for operational, quality, and compliance matters.
  • Participates in supplier qualification, audits, and performance reviews, when required.
  • Review and approve suppler documentation such as CAPAs and change controls.
  • Conducts risk assessments and support change control processes related to supplier changes.
  • Initiates, reviews and approves SCARs (Supplier Corrective Actions Reports).
  • Collaborate with internal stakeholders (QA, Regulatory, Supply Chain, Technical Operations) to resolve issues and drive continuous improvement.
  • Maintain and update Quality Agreements and ensure alignment with operational practices.
  • Supports Tech transfer Projects from a quality and compliance perspective
• Data Integrity and Data Governance
  • Lead and coordinate data integrity initiatives across departments (QA, QC, Manufacturing, IT).
  • Develop and implement data integrity policies, procedures, and training programs.
  • Conduct risk assessments and gap analyses related to data integrity.
  • Monitor compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
  • Investigate data integrity breaches and implement corrective and preventive actions (CAPAs).
  • Maintain and report on data integrity metrics and KPIs
  • Review and approve documentation related to data handling, including SOPs, protocols, and validation reports.
• Cross-Functional Collaboration
  • Works with departments like Quality Assurance, Supply Chain, Regulatory Affairs, Legal, and Operations to ensure cohesive compliance efforts.
  • Performs additional duties as assigned by reporting manager.

Qualifications

• Education: BSc in Science or Chemical Engineering or relevant experience OR 8 years related experience
• Experience: Minimum of five (5) years of experience supporting Drug and/or Medical Device Quality Management System in pharmaceutical, medical device or biotechnology industries
• Ability to travel to the pharmacy locations and travel throughout the JUBILANT business system will be up to 30% of the time
• Travel to the pharmacy locations and travel throughout the JUBILANT business system will be up to 30% of the time. This will include travel by automobile, aircraft (commercial or chartered) or other general transportation means. Must be able to operate vehicle and maintain a valid driver's license.
• Knowledge:
  • Strong knowledge of cGMP, FDA 21 CFR Part 11, EU Annex 11, and other global data integrity regulations.
  • In-depth knowledge of GxP regulations for USA, and compendia standards as well as FDA 21 CFR 212 / USP 797 and 825
  • Experience with electronic systems (e.g., LIMS, MES, ERP, CDS).
  • Ability to understand scientific issues in order to help the planning of the work
• Skills:
  • Strong communication and interpersonal skills
  • Strong organizational and time management skills
  • Solid technical writing ability
  • Dynamic
  • Teamwork
  • Result and detail oriented
  • Capacity to multi-task a number of issues at a time
  • Good analytical skills

Preferred Qualifications

• Experience with radiopharmaceuticals or PET manufacturing processes.
• Experience with FDA inspections
• Knowledge of aseptic manufacturing and sterile product requirements.
• Familiarity with validation and qualification processes for manufacturing equipment and systems.
• Experience working in or managing quality assurance for decentralized or multi-site manufacturing operations.

Why Join Jubilant Radiopharma?

At Jubilant Radiopharma, we are committed to advancing nuclear medicine through innovative radiopharmaceutical solutions. As a QA Specialist, you will play a critical role in ensuring the safety and quality of our products, making a meaningful impact on patient lives. We offer a collaborative work environment, competitive compensation, and opportunities for professional growth.

At Jubilant Radiopharma, we champion an inclusive workplace that treasures diverse perspectives, experiences, and backgrounds. We are committed to building a diverse yet inclusive workplace that is representative of the marketplace and the communities in which the Company operates.

Jubilant Radiopharma is proud to be an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status about public assistance, genetic status or any other status protected by federal, state or local law.

If qualified individuals with a disability need assistance in applying for this position, call Human Resources at 407-455-6700 informing us regarding the nature of your request and providing your contact information.

We look forward to speaking with you about this exciting new career opportunity