uniQure is dedicated to bringing therapies for unmet medical needs to patients. Each position at uniQure is directly or indirectly responsible for improving the lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and by recognizing the sense of urgency in areas of high unmet medical need.
Place in the Organization
The Associate Director of Quality Control Lab Support is responsible for 3 functional areas: LIMS Support, QC Planner, and Investigations and Continuous Improvements to maintain compliant Quality Control operations. This role supports the day-to-day operations within the Quality Control group from scheduling testing/review, data life cycle management, implementation of LIMS, and management/execution of various element of the Quality Management System (QMS), including but not limited to deviations, corrective, and preventive actions (CAPAs), laboratory investigations, out of specification results (OOS), and change controls in support of Quality Control release and stability testing.
Key result areas (major duties, accountabilities and responsibilities)
Ensures timely sample release w/ no delay to MFG and/or CoA generation
Implementation of SmartQC scheduling and forecasting tool
Implementation and management of LIMS in phased approach, including associated activities to maintain validated state
Supports cGMP QC operations through execution of Quality Management Systems including, but not limited to deviations, out of specification results, corrective and preventive action (CAPA), and change control
May perform quality metric trending as required.
Authors risk assessment as required to support QC Operations.
Collaborates with QC testing groups to author and/or review standard operating procedures, protocols, reports as required.
Represent Quality Control on project teams.
Maintain a safe, efficient, functional and compliant laboratory according to regulatory, site and corporate guidelines.
Supports internal and external audits as required, including drafting audit responses in coordination with department management and subject matter experts.
Manages the implementation/maintenance/continuous improvement of Quality Systems.
Qualifications
A minimum of a Bachelor’s degree in Life Sciences or Engineering
15 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Minimum of 5-10 years management experience.
Well versed in cGMP/ICH/FDA/EU regulations and guidelines
Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
Position requires incumbent to be capable of lifting 25 pounds and must be able to demonstrate ability to gown aseptically
Experience using LIMS
Core competencies
Strong communication skills
Strong organizational skills
Cross functional collaboration skills
Capable of working with minimal supervision
Ability to work well with diverse groups
Ability to manage multiple activities with challenging timelines