Job Description

Role Title: QC Analytical Methods & Tech Transfer Lead

Report to: Orwa Shueibi - QC Lead

Location: Virginia, Brisbane

Working Pattern: 4 office based/1 remote

You’vebuilt experience, now use it where bold ideas meet real impact. At Opella,we’rechallenging how self-care works for millions of people andneedleaders and experts ready to shapewhat’snext. As anQC Analytical Methods & Tech Transfer Lead you’llbring your skill, yourcuriosityand your drive to make health simpler,smarterand more human.

A process leadership and specialist role within Quality Control focused on analytical methods, validation, and technical transfer within a GMP-regulated laboratory environment.

This role is accountable for ensuring analytical methods received from Development Centre (DC) or external sources are effectively transferred, validated/verified, and fit-for-purpose for routine QC use.

The position acts as the single point of contact (SPOC) for PPM on QC analytical topics, ensuring alignment across stakeholders while driving method readiness, compliance, and implementation across a diverse product portfolio.

The role combines technical expertise, cross-functional coordination, and operational oversight, ensuring data integrity (ALCOA+), audit readiness, and sustainable QC operations

Main Responsibilities

Method Transfer & Implementation:

• Lead and coordinate transfer of analytical methods into QC, ensuring suitability for routine testing.
• Method Validation & Verification: Define, author, and oversee validation/verification strategies (aligned with ICH Q2(R2)), ensuring compliance and robustness.
• SPOC for PPM (QC Topics): Act as primary interface for analytical methods, results, OOS events, risks, and timelines.

Method Readiness & Gap Assessment:

• Assess incoming methods for readiness; identify gaps and drive resolution with stakeholders.
• Documentation Authoring & Governance: Prepare and/or remediate Validation/verification plans, Protocols and reports, Method summaries and traceability matrices, Supporting data packages
• Data Integrity & Compliance: Ensure adherence to ALCOA+, GMP, and audit expectations across all activities.

Operational:

• Stakeholder Collaboration: Partner with QC, QA, DC, and external laboratories to ensure aligned and compliant delivery.
• Issue Resolution: Support and contribute to OOS, deviations, and method-related investigations.
• Operational Suitability: Ensure methods are practical, efficient, and sustainable for routine QC operations.

About You

We believe that professionals with the following experience and skillsets are well-suited for this position:

• Bachelor’s or master’s degree in chemistry or relevant scientific discipline
• Strong experience in analytical method validation, verification, and tech transfer within GMP QC
• Demonstrated experience authoring and defending validation protocols and reports
• Experience with compendial and non-compendial methods
• Strong understanding of: ICH Q2(R2), ICH Q14, GMP / PIC/S requirements, Data integrity (ALCOA+)
• Proven troubleshooting capability across methods, instrumentation, and sample matrices
• Experience working with complex raw material or finished product matrices
• Strong stakeholder management and communication skillsEssential Skills & Experience

Desirable

• Experience in pharmaceutical, consumer health, or nutraceutical environments
• Familiarity with:
  • External laboratory management
  • Tech transfer governance
  • QC systems (e.g., LIMS)
  • OOS, deviations, CAPA, and change control processes
• Experience interfacing with PPM or project portfolio structures

Deliverables / Outcomes

• Successful and compliant transfer of analytical methods into QC
• Methods demonstrated to be fit-for-purpose and operationally sustainable
• Clear visibility of QC readiness, risks, and timelines
• Strong stakeholder alignment and effective issue resolution
• Audit-ready validation documentation and data integrity compliance

This is more than the next step in yourcareer,it’sa chance to lead change and help reinvent self-care for the world. Ifyou’reready to challenge, inspire and deliver impact that matters,we’reready for you. We are challengers. We are Opella.