Job Title

Third Party Quality & Analytical Senior Specialist

Requisition

JR000015715 Third Party Quality & Analytical Senior Specialist (Open)

Location

College Park, Dublin - IRL006

Additional Locations

Job Description Summary

Job Description

Keenova Therapeutics is a leading global developer and manufacturer of branded therapeutics that strives to help patients with rare or unaddressed conditions live happier and healthier lives.

Globally headquartered in Dublin, Ireland, we deliver medicines grounded in science and guided by our commitment to responsible practices.

Job Scope:

Reporting to the Associate Director Quality, this role will be responsible for supporting Analytical and Quality Operations within the Third-Party Quality Team.

This role will work to ensure the timely completion of analytical services & stability activities with a commitment to facilitate the continuous supply of quality and regulatory compliant Medicines manufactured by Third Party Suppliers. The incumbent will be responsible for ensuring that commercial customers and end users of Keenova Medicines receive safe, efficacious, pure and quality products through the establishment, maintenance and application of Quality Management Sub-Systems associated with analytical methods management, stability, and sample retention.

Key areas of responsibilities

Quality Assurance & Compliance:

Provides high level expertise of cGMP requirements, with ability to interpret regulations, guidance, and internal policies and apply them in context of compliant execution of GMP activities.
Recognizes problems proactively and develops options to solve complex problems.

Analytical Support:

Oversight, execution and management of analytical methods and specifications:
- Evaluation
- Development/ improvement
- Compendia and non-compendia update look ahead and change implementation.
- Method and product OOT/ OOS trouble shooting.
Continuous improvement of performance, compliance and efficiency of activities.
Maintenance of QA Analytical programs, policies, processes, procedures and controls.
Leads the development and validation of analytical methods and the evaluation of compendia changes/updates.
Ensures that project timelines are met and the team works in compliance with cGMP, GLPs and all other applicable requirements.
Provides guidance to other staff in review and approval of GMP documents.

Analytical Investigations:

Leads root cause identification of complex laboratory investigations.
Apprises management of the status of investigations and works with Compliance to determine if any regulatory actions are to be taken.

Stability Program Management

Oversight, execution and management of in-line routine and special cause third party manufactured product stability program.
Stability program trend and failure investigation.
Program execution metrics, monitoring and remediation as required.
Continuous improvement of performance, compliance and efficiency of activities.

Training plan

Continuous improvement of performance, compliance and efficiency of activities.

Qualifications

5+years experience in a similar role

Hons Degree in quality or other science related discipline

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

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.