What are the responsibilities and job description for the Manager, Quality Control position at uniQure?
Location: Lexington, Massachusetts (US) Education level: Bachelor / Graduate
Job category: Quality Control Target start date: 6/1/2022
uniQure is dedicated to bringing innovative therapies for unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
Place in the Organization
The Quality Control (QC) department is responsible for monitoring the quality of our AAV-based products. These activities are performed in accordance with cGMP guidelines and departmental and inter-departmental policies and standard operating procedures. The Manager – Sample Management role supports the day-to-day quality operations within the Quality Control group via oversight of all elements of sample management, LIMS, and liaising with external testing sites. The scope includes, but is not limited to, process intermediates, drug substance and drug product lot release testing as well as virus and cells banks at uniQure’s state of the art facility located in Lexington, MA. Management of quality system elements such as deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), change controls, data integrity, and training in support of Quality Control testing is also included. This role will liaise with other functional groups, including QC Technical Services, Analytical Development and Quality Assurance.
Key Responsibilities:
Maintain a safe, efficient, functional, and compliant laboratory according to regulatory, site and corporate guidelines.
Oversee day to day operation of LIMS and the sample management function.
Manage the Laboratory Information Management System (LIMS).
Perform and /or manage staff who perform activities such as dispensing bulk drug substance into sample aliquots, labelling, distributing samples to test laboratories, including samples to shipped to external facilities.
Act as point of contact with external testing laboratories.
Manage the storage and archival of data records.
Provide effective leadership to manage staff to achieve objectives.
Ensure staff are trained and professional development is encouraged.
Ensure compliance to national and international regulations and pharmacopoeia and make continuous improvements accordingly.
Support strong interactions and partnerships with cross functional teams.
Maintenance of critical laboratory supplies required to perform the sample management function.
Support cGMP Quality Control operations through execution of Quality Management Systems including, but not limited to, change controls, deviations, Out of Specification, Out of Tolerance and Corrective and preventive action (CAPA).
May author risk assessments as required to support QC Operations.
Supports internal and external audits as required including drafting audit responses in coordination with department management and subject matter experts.
Represent Quality Control on project teams and in meetings as required.
Authors standard operating procedures as required.
Implement continuous improvements within Quality Control which may include updates to Standard Operating Procedures, training procedures, training profiles and records for personnel, and data management system(s), etc.
Review and approval of data and documentation, where applicable.
Authors and/or reviews documentation such as investigations and standard operating procedures.
Identify and implement Continuous Improvements.
Perform quality metric trending as required.
Partner with QC Technical Services, Stability, Analytical Development, and Quality Assurance groups.
Represent QC at inter-departmental meetings and liaise with cross functional departments as needed.
May support of Regulatory Submissions of INDs, NDAs, etc.
Other duties, as assigned.
Educational and Other Requirements
A minimum of a Bachelor degree in Life Sciences or Engineering
5-10 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Minimum 5 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
Large molecule, gene or cell therapy experience is required.
Excellent analytical and problem-solving skills
Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
Must possess excellent communication and organizational skills.
Strong organizational skill
Capable of working with minimal supervision
Ability to work well with diverse groups
Ability to manage multiple activities with challenging timelines
Core competencies
Strong communication skills
Strong organizational skill
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
Job category: Quality Control Target start date: 6/1/2022
uniQure is dedicated to bringing innovative therapies for unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the lives of patients. This responsibility should be part of our day-to-day working life by (i) living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.
Place in the Organization
The Quality Control (QC) department is responsible for monitoring the quality of our AAV-based products. These activities are performed in accordance with cGMP guidelines and departmental and inter-departmental policies and standard operating procedures. The Manager – Sample Management role supports the day-to-day quality operations within the Quality Control group via oversight of all elements of sample management, LIMS, and liaising with external testing sites. The scope includes, but is not limited to, process intermediates, drug substance and drug product lot release testing as well as virus and cells banks at uniQure’s state of the art facility located in Lexington, MA. Management of quality system elements such as deviations, corrective and preventive actions (CAPAs), investigations, Out of Specifications (OOS), change controls, data integrity, and training in support of Quality Control testing is also included. This role will liaise with other functional groups, including QC Technical Services, Analytical Development and Quality Assurance.
Key Responsibilities:
Maintain a safe, efficient, functional, and compliant laboratory according to regulatory, site and corporate guidelines.
Oversee day to day operation of LIMS and the sample management function.
Manage the Laboratory Information Management System (LIMS).
Perform and /or manage staff who perform activities such as dispensing bulk drug substance into sample aliquots, labelling, distributing samples to test laboratories, including samples to shipped to external facilities.
Act as point of contact with external testing laboratories.
Manage the storage and archival of data records.
Provide effective leadership to manage staff to achieve objectives.
Ensure staff are trained and professional development is encouraged.
Ensure compliance to national and international regulations and pharmacopoeia and make continuous improvements accordingly.
Support strong interactions and partnerships with cross functional teams.
Maintenance of critical laboratory supplies required to perform the sample management function.
Support cGMP Quality Control operations through execution of Quality Management Systems including, but not limited to, change controls, deviations, Out of Specification, Out of Tolerance and Corrective and preventive action (CAPA).
May author risk assessments as required to support QC Operations.
Supports internal and external audits as required including drafting audit responses in coordination with department management and subject matter experts.
Represent Quality Control on project teams and in meetings as required.
Authors standard operating procedures as required.
Implement continuous improvements within Quality Control which may include updates to Standard Operating Procedures, training procedures, training profiles and records for personnel, and data management system(s), etc.
Review and approval of data and documentation, where applicable.
Authors and/or reviews documentation such as investigations and standard operating procedures.
Identify and implement Continuous Improvements.
Perform quality metric trending as required.
Partner with QC Technical Services, Stability, Analytical Development, and Quality Assurance groups.
Represent QC at inter-departmental meetings and liaise with cross functional departments as needed.
May support of Regulatory Submissions of INDs, NDAs, etc.
Other duties, as assigned.
Educational and Other Requirements
A minimum of a Bachelor degree in Life Sciences or Engineering
5-10 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment
Minimum 5 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
Large molecule, gene or cell therapy experience is required.
Excellent analytical and problem-solving skills
Proficient in using Microsoft applications (MS Word, MS Excel, MS PowerPoint)
Must possess excellent communication and organizational skills.
Strong organizational skill
Capable of working with minimal supervision
Ability to work well with diverse groups
Ability to manage multiple activities with challenging timelines
Core competencies
Strong communication skills
Strong organizational skill
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
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