USA - Safety and Regulatory Quality Control - V - USD

Joulé; Collegeville (PA); Hybrid; USD 135,200; Full time

Benefits offered by this job

Health benefits

401(k) participation

Work from home flexibility

Job summary

A global pharmaceutical organization is seeking a Contractor Quality & Regulatory Lead to oversee product quality and compliance for external manufacturers. This role demands over 10 years of experience in GXP settings and requires expertise in regulatory affairs and quality management processes. The ideal candidate will work in a hybrid model, balancing remote oversight with necessary site visits. Strong leadership, communication, and project management skills are essential for success in this high-impact role.

Qualifications

• Minimally 10 years of experience in GXP setting or Regulatory Affairs.
• Expertise in external suppliers and Change Management processes.
• Knowledge of US, European, and global cGMPs.

Responsibilities

• Manage product quality for external contract manufacturers.
• Provide Quality Leadership and regulatory expertise.
• Assess quality of external suppliers' products.

Skills

GXP experience

Regulatory Affairs

Project Management

Strong Communication Skills

Problem Solving

Leadership Skills

Tools

QTS & eQMS modules

Job description

Job Title: USA - Safety and Regulatory Quality Control - V
Location: Southern, CA - Must currently reside in CA
Type: Contract
Compensation: $65/hr
Contractor Work Model: Hybrid - Work from home with travel to sites in North San Diego, South and east of Ocean Side; Sana Monica north of Long Beach
Hours: 40.0

Overview

We are partnering with a global, highly respected pharmaceutical organization to identify a Contractor Quality & Regulatory Lead (CQRL) to support a complex external manufacturing network. This is a high-impact role at the intersection of Quality, Regulatory, and External Manufacturing, where you will play a critical role ensuring that products manufactured by external partners meet the highest standards of quality, compliance, and regulatory alignment across global markets. If you thrive in a fast-paced, cross‑functional environment and enjoy owning quality decisions, regulatory change strategy, and external partner oversight, this opportunity offers strong visibility and influence across a global organization.

Responsibilities

• Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers that supply materials/product(s) 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 suppliers' 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 client requirements.
• Influence quality decision making in line with industry and client 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.
• Support Post‑Approval Changes, initial registrations, and/or renewals.
• Review & assess changes affecting ESOQ managed CMOs by performing regulatory impact assessments in collaboration with Regulatory Strategists as needed.
• Act as a liaison between CMOs, VSOTs, PGS sites within the Global CMC organization, Regional Strategist (if required).
• Raise Change Management eQMS records, facilitate PAC creation, and open regulatory Product Change Forms (PCF) for CMO or client 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 client sites as required.
• Monitor and notify the CMO and VSOT through the escalation process of regulatory submission status, BOH queries, commitments, and approvals.
• Support in Dossier Compliance Assessment and New Regulations/Compendia requirements implementation as required.
• Contribute to QRTs and support on‑site investigation, regulatory discrepancies, and other relevant activities impacting QRTs decisions.
• Identify, develop, and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest standards.
• Ensure tracking and documentation of all required quality‑related actions in relevant systems and follow escalation processes.
• Lead and support complex investigations, market complaints, risk assessments, and connect with SMEs as needed.
• Support Global Logistics and Network Services team to maintain GDP oversight during manufacture and shipping of medicinal products.
• Work independently, receiving instructions primarily on unusual or complex problems.
• Build, maintain, and develop relationships with key stakeholders, both internal and external.
• Support ESOQ leadership in other tasks & projects as required.
• Support the management of Expedited Product Quality Complaints.
• Perform regulatory impact assessments for Change Management, including reviewing requirements, evaluating timelines, and supporting deployment of registered information.
• Support License Renewals, New product registrations, Product Launches, Site Transfers, License Withdrawals, and Tender applications.
• Support generation and collection of ancillary documents as applicable.

Requirements

• Minimally 10 years of experience in GXP setting and/or Regulatory Affairs role.
• Expertise in external suppliers/contractors, Change Management, and Regulatory processes.
• Experience with relevant QTS & eQMS modules.
• Demonstrated technical know‑how, knowledge of US, European, and global cGMPs, compliance issues, inspectional trends, and industry quality assurance practices.
• Strong communication skills—diplomatic, clear, and succinct with internal and external stakeholders.
• Commitment to Change Management Best Practices and embracing innovation.
• Strong project management skills with success leading global projects.
• Collaborative mindset aligned with client‑focused values: Courage, Equity, Excellence, Joy.
• Proficient in English with strong technical writing, verbal, and presentation skills.
• Decision‑making based on a science‑based risk approach.
• Proven ability to manage complex quality and compliance activities, problem solve, and take initiative.
• Ability to work independently and report as required to line management.
• Proven leadership and facilitation skills, capable of involving multiple organizational levels to meet objectives.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #568-Clinical