Manager - External Supply Operations Quality

Join a Global Leader in Workforce Solutions – Net2Source Inc.

Who We Are
Net2Source Inc. isn't just another staffing company, we're a powerhouse of innovation, connecting top talent with the right opportunities. Recognized for 300% growth in the past three years, we operate in 34 countries with a global team of 5,500+. Our mission? To bridge the talent gap with precision—Right Talent. Right Time. Right Place. Right Price.

Title: External Supply Operations Quality (ESOQ Manager)
Duration: 15 months contract
Location: Remote (with 20% travel to client sites)

Shift: Standard Business Hours

Position Summary
• The Global External Quality Operations Mission is "to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.”
• External Supply Operations Quality (ESOQ) is committed to supporting Client Global Supply (PGS) as an innovative and competitive advantage by assuring the quality of products manufactured and packaged by other companies (Contractors).
• ESOQ is responsible for the Quality & Regulatory management of approximately 300 contract manufacturers, packagers, and supply partners globally.

Responsibilities
• The ESOQ Manager holds overall accountability for assigned CMOs, with primary responsibility for quality oversight (approximately 80%) and secondary responsibility for regulatory oversight (approximately 20%) across operational activities.
• The ESOQ Manager is accountable for providing quality assurance management of key contractors and for assuring that the products supplied to patients are manufactured & tested in accordance with c-GMPs, the registration file and any additional country specific requirements.
• This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Client.
• (S)he will operate as spokesperson for ESOQ and will focus on developing relationships, independently negotiating, developing and communicating Client quality requirements with contract manufacturers.
• ESOQ Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D) and will lead virtual cross functional teams.
• Initiate, review and approve regulatory changes through Client enterprise system (i.e. PDM) for changes initiated by or impacting ESOQ managed contractors.
• Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product Registrations and Post approval variations.
• Main point of contact for Global Chemistry, Manufacturing & Controls (CMC) or Local Regulatory Affairs in Client Country Offices for the regulatory activities involving the ESOQ contractors.
• As the Quality & Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.
• Support and Perform Lot Disposition for Biotech semi-finished and finished products (if applicable).

Qualifications

Education:
• Minimally BA/BS Science, Engineering, or related technical discipline

Experience:
• At least 7 years in a GXP setting and/or Regulatory Affairs role
• At least 4 years of Product Quality Assurance experience in a GMP environment with Aseptic manufacturing experience

Skills:
• Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM, Documentum platforms
• Command of English language required and multi-lingual is a benefit
• Strong verbal and written communication including presentation skills
• Shows strong negotiation skills and is diplomatic in communication with internal and external customers
• Demonstrated ability to manage multiple projects and priorities
• Demonstrated ability to prioritize work, to act and work independently and to escalate items as required to Team leader
• Demonstrated excellent organization skills
• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor
• Developing personal leadership to manage cross functional projects
• Developing ability to resolve conflicts
• Takes initiatives and is proactive, persistent
• Has a broad GMP and technical know-how to handle emerging issues
• Able to report remotely and deliver work independently
• Up to 20% travel may be required

Why Work With Us?
We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.

Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.

Awards & Recognition
• America's Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1

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