Job Title: Safety and Regulatory Quality Control - V
Location: Southern, CA (HYBRID)
Duration: 15+ Months (Possibility of extension depending upon business requirements and performance)
Shift: 8-5
 
Sites to be working:

• North San Diego, South and east of Ocean Side; Sana Monica north of long beach

 
Manager Notes:

• Overseeing quality FDA regulated environment GMP is a must
• Validation work, doc review, quality or technical perspective
• Evaluate change control, investigations, work within contracts, evaluations Not usually writing them but good technical writing skills, get ready for commercial distro, quality manager at pharm site.
• Interaction with team is heavy, lots of global impact Ireland and remote co-development space virtual site operating team all virtual team
• Peptides, biometrics, software: viva vault, SAP, two key systems exp.
• Good people skill, project management, works well under pressure, high visibility project for organization, accelerated timelines, high stress.
• being agile think outside the box, think critically, give and receive feedback going to be doing a lot of that for reviews
• 10 years Do they have background in FDA regulated industry- not particular on where, but in QC, QA, technical pharm sci, in related field.
• Tech services background can be useful
• Biologics experience, active ingredient drug substances experience

 
Role Description:

• The Contractor Quality & Regulatory Lead (CQRL) actively contributes as part of the ESOQ Tier 2 structure to ensure that organization network of External suppliers/CMOs/partners are 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), which works collaboratively with Contract Manufacturing Organizations (CMOs), Virtual Site Operating Teams (VSOTs), and Regulatory colleagues to determine when the Regulatory Change Management Process is required.

 
Responsibilities:

• Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials/product(s) to organization 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, including RQA audits or regulatory inspections, as applicable.
• Support internal and external partners with Compliance Assessments to ensure current CMP/GDP adherence.
• Support onboarding activities of new CMOs 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 organization requirements.
• Influence quality decision making in line with industry and organization 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, 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 organization Country Offices (PCO)
• Raise Change Management eQMS records, facilitate PAC creation and discussion within the VSOT and open regulatory Product Change Form (PCF) for CMO or organization-initiate Poast 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 organization 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 products.
• Work independently, receive instructions primarily on unusual or complex problems.
• Build, maintain and develop relationships with key stakeholders, both internal and external to organization.
• Support ESOQ leadership in other tasks & projects as required.
• Support the management of Expedited Product Quality Complaints.

 
Regulatory Change Management:

• Perform regulatory impact assessment by comparing the current registered information with the proposed changes 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?
• Ass 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 organization 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 section 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 PAC process in the VSOT
• Raise the Product Change Form (PC) in PDM to clearly specify the change form and to with justification, product impacted, specific markets impacted where the change will not impact on 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 notification s 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 BOH approval is received, any BOH commitments made, and the 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 10 years of experience in GXP setting and/or Regulatory Affairs role
• Expertise in external suppliers/contractors, Change Management and Regulatory.
• Experience w/ 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 organization 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 and 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.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 60.00/hr.