Senior Specialist, External Quality Operations

Keenova Therapeutics plc; Bridgewater, Northern (MA, KY); Hybrid; USD 80.000 - 129.000; Vollzeit

Benefits dieser Stelle

Total Rewards package

Bonus eligibility

Zusammenfassung

Keenova Therapeutics plc is seeking a Senior Specialist, External Quality Operations to support externally manufactured products in a fully remote role. You will manage CMOs, oversee batch documentation, and ensure timely manufacture and quality issue resolution.

The position requires a Bachelor’s degree in a scientific field and 5–7 years of quality systems experience, including deviations, change controls, and supplier qualification.

Qualifikationen

• Bachelor’s degree in a scientific discipline; +5–7 years’ experience as a Quality Specialist.
• Experience with Quality Systems including deviations, change controls, training, supplier qualification and document management systems.
• Knowledge of cGMP for pharmaceutical manufacturing and GDP and ISO 13485.

Aufgaben

• Batch review and approval of CMO documentation for batch production.
• Oversee CMO governance and management of third‑party activities.
• Quality record management, deviations, changes, CAPAs and document control.
• Monitor cold-chain transportation and ensure qualification and routine checks.
• Manage audits, readiness, and continuous improvement projects with CMOs and Keenova.

Kenntnisse

Quality Systems

cGMP Knowledge

GDP Knowledge

ISO 13485 Knowledge

Documentation Management

Ausbildung

Bachelor’s Degree in scientific discipline

Tools

Document Management Systems

Jobbeschreibung

## Senior Specialist, External Quality OperationsApply: Fully Remote: Bridgewater, NJ: Malvern, PA: Full time: Posted Yesterday: JR000016029**Job Title**Senior Specialist, External Quality Operations**Requisition**JR000016029 Senior Specialist, External Quality Operations (Open)**Location**Bridgewater, NJ**Additional Locations**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.**Job Description****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:**EducationBachelor’s Degree in scientific discipline, preferred +5-7years’ experience working as a Quality Specialist. ExperienceDirect experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)Preferred SkillsKnowledge 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. 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 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. 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: 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.