Senior Specialist, External Quality Operations

About the role

The Senior Specialist, External Quality Operations supports externally manufactured products for Keenova with a product portfolio that includes pharmaceutical and biopharmaceutical products. The position is responsible for building, maintaining and managing the relationship with their counterparts at the CMO and cross-functional team members. The position is responsible for appropriate escalation to Manager/Director level management and above. Reports to: Senior Manager, External Quality Operations. This position works in a remote, office type environment with limited travel as needed.

Responsibilities

• Batch Review: Preparation, review and approval of CMO documentation for batch production; review of batch records, addressing discrepancies and escalating where required to management; preparation of disposition and release certification for reviewed batch records.
• CMO Governance: Management and oversight of third-party supplier activities relating to the manufacture, packaging and testing of product; regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product; continuous monitoring of product and performance from CMOs.
• Quality Support and Deputation: Quality record management; deviations, change controls, CAPAs; monitoring cold-chain transportation, for both qualification and routine; CMO Maintenance; input into Technical Quality Agreements; post-launch support for quality activities in various countries, as needed; management of delegated projects.
• Stability Program: Protocol review and approval; data review and management.
• Audits: Drive the audit readiness program to always ensure audit compliance.
• Quality/QMS Projects: As required; champion continuous improvement efforts for projects identified at the CMOs or within Keenova.

Qualifications

• Education: Bachelor’s Degree in scientific discipline, preferred.
• Experience: +5‑7 years’ experience working as a Quality Specialist.

Skills

• Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems).
• Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485.

Pay

The expected base pay range for this position is $80k– $129k. This position is eligible for a bonus in accordance with the terms of the applicable program; bonuses are awarded at the Company’s discretion.

Benefits

Keenova offers employees a Total Rewards package which includes competitive pay and benefits. To learn more about our Total Rewards benefits please visit: Keenova Careers | Serve and Grow with Purpose | Keenova.