GMP Investigation Lead, Quality Control

The Position

This position resides within the Quality Control function under the Quality Organization. The GMP Lead Investigator is responsible for leading, authoring, and managing deviations; OOS/OOT/Atypical laboratory investigations; and associated change control records arising from analytical testing activities. These activities include testing of environmental monitoring samples, pharmaceutical raw materials, in‑process manufacturing samples, finished drug substances and drug products, and stability samples for new drug substances and drug products within a GMP environment.

The incumbent will embody a GMP‑compliant quality mindset, driving excellence, continuous improvement, and ethical practices to ensure regulatory compliance and sustain the highest standards of quality. The GMP Lead Investigator serves as the primary Quality Control representative, overseeing and coordinating all investigation‑related activities conducted by the Quality Control team.

Responsibilities

• Serve as Lead investigator and ensure the timely completion of high quality, robust GMP investigations with clearly defined and scientifically sound root cause determination
• Develop, justify, and oversee the implementation of effective Corrective and Preventative Actions, (CAPAs) to prevent recurrence.
• Conduct structured, science-based root cause analysis (RCA) using approved methodologies (5-Whys, Ishikawa, Fault Tree, etc)
• Escalate events to management when they represent potential significant quality risks or may impact investigations closure timelines or product release
• Support regulatory inspections and internal/external audits by maintaining inspection readiness and serving as a subject matter expert (SME) as needed.
• Contribute to site Quality Operations compliance activities in alignment with Arrowhead standards, procedures and cGMP requirements.
• Collaborate cross functionally with site personnel to provide guidance and drive resolution of end-to-end manufacturing and quality issues.
• Ensure accurate, complete, timely documentation and review of Quality Control investigations, CAPAs, Change Controls and complainants.
• Evaluate historical data, trends and prior investigations for recurrence or systemic issues and opportunities for proactive improvement.
• Support the maintenance and improvement of investigation compliance metrics
• Participate in and contribute to continuous improvement initiatives related to the investigation and CAP processes.
• Work independently while also collaborating effectively with cross – functional partners, including Manufacturing, Quality Assurance, Supply Chain and Project managers, external partners.
• Perform detailed review of batch records, stability reports, Raw material, Environmental monitoring reports, equipment logs, in-process testing, data review and other duties assigned

Requirements

• A minimum B.S. in Chemistry (or related field) with 5+ years’ work experience is required. Preferably candidate with working experience in Pharmaceutical and /or oligonucleotide manufacturing.
• Knowledge of cGMP and GDP, iCH and FDA/EU guidance.
• Great attention to detail and ability to follow procedures.
• Demonstrate proficiency with a variety of instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, Endotoxin plate readers, pH, Osmo and/or Raman etc.

Preferred

• Excellent organizational skills with the ability to simplify and clearly communicate complex quality and technical concepts.
• Excellent verbal, written, and presentation skills, including the ability to clearly articulate investigation outcomes, risk assessments, and decisions.
• Demonstrated ability to interpret quality issues and determine scientifically sound, compliant resolutions that minimize risk and withstand regulatory scrutiny.
• Strong ability to collaborate effectively with stakeholders, customers, and peers to drive timely resolution of quality issues across the product lifecycle.
• Proven decision‑making capability, with the ability to think critically and creatively while maintaining compliance, quality standards, and GMP expectations.
• Ability to assess the criticality of quality issues and clearly communicate complex risks, trends, and investigation outcomes to management.
• Demonstrated understanding and application of ICH Q10 Pharmaceutical Quality System principles, including risk management, CAPA effectiveness, knowledge management, and continuous improvement across the product lifecycle.
• Capability to support and maintain a state of inspection readiness through accurate, complete, and traceable documentation aligned with cGMP and data integrity expectations.
• Proficiency in Microsoft Office Suite and QMS systems such as Veeva and experience with LIMS.