Senior Specialist, External Quality Operations

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Provide support for externally manufactured pharmaceutical and biopharmaceutical products.

• Establish, nurture, and oversee relationships with CMO counterparts and cross-functional team members.

• Review and authorize CMO batch-production documentation.

• Examine batch records, address any discrepancies, and escalate issues to management as necessary.

• Prepare disposition and release certification for the evaluated batch records.

• Oversee CMO governance and manage third-party manufacturing, packaging, and testing activities.

• Communicate with CMOs to ensure timely manufacturing and to resolve quality issues.

• Monitor the performance of products and CMOs.

• Manage quality records, including deviations, change controls, and CAPAs.

• Oversee cold-chain transportation qualification and routine operations.

• Contribute input into Technical Quality Agreements.

• Assist in post-launch quality activities across various countries.

• Manage assigned projects.

• Review and approve stability program protocols.

• Review and manage relevant data.

• Promote audit readiness and compliance.

• Lead continuous improvement initiatives at CMOs and within Keenova.

⛳️ Requirements

• Bachelor’s Degree in a scientific discipline is preferred.

• 5–7 years of experience as a Quality Specialist.

• Direct experience with Quality Systems, including deviations, change controls, training, supplier qualification, and document management systems.

• Familiarity with cGMP requirements for pharmaceutical manufacturing.

• Knowledge of GDP and ISO 13485 standards.

• Ability to work in a remote, office-type environment.

• Limited travel may be required as needed.

🏝️ Benefits

• Competitive salary and benefits package.

• Eligibility for bonuses in line with the applicable program.

• Flexible remote work arrangements.

• Limited travel as necessary.