Senior Specialist, External Quality Operations

Keenova Therapeutics plc; United States; Remote; USD 80,000 - 129,000; Full time

Benefits offered by this job

Total Rewards package

Bonus eligibility

Job summary

Keenova is seeking a Senior Specialist, External Quality Operations to manage externally manufactured products and build strong relationships with CMOs. The role includes batch review, release activities, and governance across a multinational supply chain.

You will work with cross-functional teams to ensure compliance with quality systems and regulatory expectations. The role emphasizes collaboration with CMOs, continuous improvement, and post-launch support while maintaining rigorous oversight

Qualifications

• Bachelor's Degree in scientific discipline; preferred 5–7 years' experience as a Quality Specialist.
• Direct experience with Quality Systems (deviations, change controls, training, supplier qualification and document management systems).

Responsibilities

• Batch review and approval of CMO documentation for batch production.
• Review batch records, address discrepancies and escalate as needed to management.
• Prepare disposition and release certification for reviewed batch records.
• CMO governance; oversight of third-party supplier activities for manufacture, packaging and testing.
• Regular communication with CMOs to ensure timely manufacture and resolve quality issues.
• Continuous monitoring of product and performance from CMOs; quality record management including deviations, change controls, CAPAs.
• Monitor cold-chain transportation, qualification and routine CMO maintenance.
• Input into Technical Quality Agreements; post-launch quality activities support.
• Management of delegated projects; stability program; protocol review and approval; data review and audits.
• Drive the audit readiness program to ensure constant audit compliance.
• Champion continuous improvement efforts for projects identified at CMOs or Keenova.

Skills

cGMP knowledge

GDP knowledge

ISO 13485 knowledge

Quality systems

Education

Bachelor's Degree in scientific discipline

Job description

Job Title: Senior Specialist, External Quality Operations

Requisition: JR000016029

Location(s): 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
• Champion continuous improvement efforts for projects identified at the CMOs or within Keenova

Qualifications

• Education: Bachelor's Degree in scientific discipline, preferred +5-7 years' 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.

Salary and Benefits

Keenova offers employees a Total Rewards package which includes competitive pay and benefits.

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.

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.

At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Keenova and let’s do something dynamic together.

Equal Employment Opportunity

Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.

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.