Essential Functions

• Batch Review

o Preparation, review and approval of CMO documentation for batch production

o Review of batch records, addressing discrepancies and escalating where required to management.

o Preparation of disposition and release certification for reviewed batch records.

• CMO Governance

o Management and oversight of third-party supplier activities relating to the manufacture, packaging and testing of product.

o Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product.

o Continuous monitoring of product and performance from CMOs.

• Quality Support and Deputation

o Quality record management; deviations, change controls, CAPAs

o Monitoring cold-chain transportation, for both qualification and routine

o CMO Maintenance

o Input into Technical Quality Agreements

o Post-launch support for quality activities in various countries

o Management of delegated projects

• Stability Program

o Protocol review and approval

o Data review and management

• Audits

o Drive the audit readiness program to ensure audit compliance at all times.

o Perform supplier audits as required (CQA certification preferred)

• Quality/QMS Projects

Minimum Requirements

Education / Experience / Skills:

• Bachelor’s Degree in scientific discipline, preferred 5 years’ experience working within Quality roles with increasing responsibility.

• Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)

• Knowledge of cGMP requirements for pharmaceutical manufacturing, specifically CFR 210/211 and CFR 820; knowledge of GDP and ISO 17025 and 13485

• CQA and/or CSQP certification preferred.