Senior Specialist, External Quality Operations

Mallinckrodt; Bridgewater (MA); A distancia; USD 80.000 - 129.000; Jornada completa

Descripción de la vacante

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products and collaborate with CMOs. You will build relationships with counterparts, escalate to senior management, and drive continuous improvement in quality systems.

The role involves batch review, document control, and ensuring compliance with cGMP, GDP, and ISO 13485 across multiple countries. A remote/office setup and limited travel may apply.

Formación

• Bachelor's degree in a scientific discipline with 5–7 years of quality operations experience.
• Direct experience with Quality Systems (deviations, change controls, training, supplier qualification and document management)
• Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485.

Responsabilidades

• Batch review preparation, review and approval of CMO documentation for batch production.
• Review 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
• Audits Drive the audit readiness program to always ensure audit compliance

Conocimientos

cGMP knowledge

GDP ISO 13485 knowledge

Educación

Bachelor's Degree in scientific discipline

Descripción del empleo

Job Title

Senior Specialist, External Quality Operations

Requisition

JR000016029 Senior Specialist, External Quality Operations (Open)

Location

Bridgewater, NJ

Malvern, PA

Job Description Summary

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.

Key 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 +5-7years' experience working as a Quality Specialist.

Experience

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

Preferred Skills

Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485

Organizational Relationship/Scope

Reports to: Senior Manager, External Quality Operations

Working Conditions

This position works in a remote, office type environment. Limited travel as needed.

Total Rewards

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

Salary

The expected base pay range for this position is $80k- $129k. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.

Bonus

This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion.

Disclaimer

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

#LI-REMOTE

#LI-GN1

Company Culture

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support-showing up in big moments and small to help patients find comfort and confidence.

We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men's health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference.

We are Keenova-keen to solve, keen to serve. Learn more at www.keenova.com .