Senior Associate (Contractor Quality & Compliance)

Contractor Quality & Regulatory Lead

The Contractor Quality & Regulatory Lead (CQRL) ensures that a network of external suppliers/CMOs/partners is supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines/applicable GMP/GDP regulations. The CQRL is also the liaison between the site and Global Regulatory Science (GRS), working collaboratively with Contract Manufacturing Organizations (CMOs), Virtual Site Operating Teams (VSOTs) (External Supply), and Regulatory colleagues to determine when the Regulatory Change Management Process is required.

Responsibilities include managing all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials/products to *** according to established procedures. Provide Quality Leadership and act as regulatory expert within the VSOT, advising of regulatory strategy and potential supply constraints if any. Assess the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems are maintained. Support internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors - (RQA audits or regulatory inspections) as applicable. Support internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence. Support onboarding activities of new CMO's or product launches within the portfolio as applicable. Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and *** requirements. Influence quality decision making in line with industry and *** requirements Partner with colleagues to develop and negotiate Quality Agreements. Review and approve Annual Product Review and Product Quality Review (APR/PQR) reports and relevant product stability reports. On time endorsement of Product. Support Post Approval Changes (Client), initial registrations and/or renewals. Review & assess the changes affecting ESOQ managed CMOs by performing regulatory impact assessment in collaboration with Regulatory Strategists as needed. Assume ownership of changes as described in associated change control procedures and processes to ensure timely progression of activities to support change completion Act as a liaison between CMOs, VSOTs, PGS sites within the Global CMC organization, Regional Strategist (if required) or *** Country Offices (PCO) Raise Change Management eQMS records, facilitate Client creation and discussion within the VSOT, and open regulatory Product Change Form (PCF) for CMO or ***-initiated Post Approval Changes with potential regulatory impact. Coordinate the collection of supporting documents for Post Approval Changes, initial registration, renewals, and BOH queries from CMOs (ESOQ CRL) and PGS sites (PGS SCNM) as required. Monitor and notify the CMO and VSOT through the escalation process of regulatory submission status, BOH queries, commitments, and approvals. Act as regulatory expert for CMO liaising with *** GRS and supporting systems (e.g., RRM, PEARL, GDMS etc.) Support in Dossier Compliance Assessment and New Regulations/compendia requirements implementation as required and involve the CQL appropriately. Actively contribute to QRTs and support on site investigation, regulatory discrepancies and any other relevant activity impacting QRTs decisions. May Identify, develop and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards. Ensure the adequate tracking and documentation of all required quality related actions in the relevant system(s) and that all required escalation processes are followed. Lead and support complex investigations, market complaints, risk assessments in support of products within your portfolio. Connect with SMEs where needed. Support Global Logistics and Network Services team to ensure GDP oversight is maintained during manufacture and shipping of medicinal product. Work independently, receive instructions primarily on unusual or complex problems. Build, maintain and develop relationships with key stakeholders, both internal and external to ***. Support ESOQ leadership in other tasks & projects as required. Support the management of Expedite Product Quality Complaints Regulatory Change Management Perform regulatory impact assessment by comparing the current registered information with the proposed change to determine in collaboration with the Global Regulatory / Country Regulatory Lead /CMC strategist if Regulatory Change is required. Review the regulatory requirements or guidelines (including from Regulatory Requirements Manager [RRM]) to evaluate possible requirements in collaboration with GCMC. As needed, determine best case and worst case BOH approval timelines, align with Global CMC on timelines as needed, and share high-level estimation of the BOH approval timelines with the CMO, VSOT and PGS project team (if available). If appropriate, support the deployment and maintenance of *** Common Technical Dossier (P-CTD) for the sharing of registered information to the CMO in collaboration with the VSOT If P-CTD is not deployed, share the latest approved CTD sections with the CMOs after collecting them in PDM. Share the preliminary market regulatory impact assessment with the CMO, VSOT and PGS project team (if available). For changes impacting multiple sites, the CQRL should ensure that impacted sites are being informed of the proposed changes and obtain their concurrence prior to the implementation through the Global Change Request and Site Impact Assessment record in QMS. Coordinate collection of regulatory supporting documents for the change control and registration as needed. Support the Client process in the VSOT Raise the Product Change Form (PCF) in PDM to clearly specify the change from and to with justification, products impacted, specific markets impacted where the change will not impact all markets, other impacted sites, and upload the supporting documents in collaboration with the GRL by the agreed timeline. For products in PDM, route the PCF for Global CMC Market Impact Assessment. Obtain from the CMO or other stakeholders as required and upload additional information when requested by Global CMC to justify the change and support market requirements. Communicate the Market Impact Assessment (MIA) feedback from Global CMC or PCO (for single market products not in PDM) to the CMO, VSOT and PGS project team (if available). Track regulatory submission status and approvals & rejections within digital system Monitor for BOH Queries through notifications from GCMC or the PCO. Support Global CMC or PCO in completion of BOH queries. Inform the site and obtain the required documentation from the site to support the BOH queries. Inform the site and PGS project team (if available) when specific markets are authorized to be implemented, when a BOH approval is received, any BOH commitment made, and BOH implementation date (if required). Escalate critical quality/compliance issues or major delays following the standard SOP/IMEx / VSOT reporting meetings. Support License Renewals, New products registrations, Product Launches, Site Transfer, License Withdrawals and Tender applications following the same approach as above. Support generation and collection of ancillary documents if applicable

Qualifications/Skills: Minimally 5 years of experience in GXP setting and/or Regulatory Affairs role (Pertinent Master's degree required). Expertise in external suppliers/contractors, Change Management and Regulatory. Experience with relevant QTS & eQMS modules. QRM practitioner. Demonstrated technical know-how, knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices. Is diplomatic, clear & succinct in communication with internal and external stakeholders. Committed to the Change Management Best Practices to enable improvement of the Change Management Process and System. Embraces innovation and change to find solutions. Strong project management skills. Demonstrated success leading global Projects. Collaborative and embraces *** mindset: Courage, Equity, Excellence, Joy, strong interpersonal and influential skills. Proficient in English and technical writing and strong verbal, written communication, and presentation skills. Decision-making based on a science-based risk approach. Demonstrated experience managing complex quality & compliance activities, problem solving attitude and open to innovation, takes initiatives and is proactive, persistent. Demonstrated ability to act and work independently and to report items as required to line manager. Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives.