uniQure
Associate Director, QC Data Management
uniQure, Lexington, Massachusetts, United States, 02173
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Associate Director, QC Data Management
role at
uniQure
uniQure is dedicated to bringing innovative therapies or 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.
The Associate Director, QC Data Management will play a pivotal role in the advancement of uniQure’s gene therapy pipeline and be responsible for overseeing processes related to QC data management for the various (AAV-based) products, throughout their development phases, both clinical and commercial.
Primary responsibilities include: (1) developing and maintaining a data management strategy and enhancing overall control over data integrity and reliability, leading and mentoring QC analysts and other data professionals; (2) generating and maintaining data overviews per program, and implementing/utilizing data analysis techniques to identify trends and anomalies, as well as signal a need for action; (3) providing oversight and technical input to support closure of any deviations and/or OOS’s related to QC testing, and working with QA to help enable timely release and supply of products; (4) technical review of documentation summarizing/utilizing QC data.
The position requires a keen interest in product data/product quality and strong problem-solving capabilities, helping to address quality issues that can lead to operational inefficiencies/delays and/or financial loss, including having the technical background to fully understand the analytical methods used to generate the data. The position also requires strong collaborative skills, and mentoring/guiding skills working within QC and across departments to ensure (data) quality standards are met and governance principles are followed throughout the organization.
Responsibilities
Developing/continuously improving the overall data management strategy within the context of an outsourcing model (testing performed by CLOs);
Working within uniQure with data integrity & reliability experts, providing a framework/approach both for internal and external QC activities related to data generation/acquisition & data reporting;
Mentoring on data management within QC as well as within the larger TOQ organization;
Data overviews, cross-departmental communication, supporting timely release of products
Gathering program specific data into data overviews that are maintained for communication purposes as well as being a (controlled) basis for study reports and (regulatory) submissions;
Partnering with internal and external teams to meet timelines and company objectives, including internally with Non-clinical Development, Product Development (AD/DSD/DPD), Quality Assurance, Regulatory, and externally with CROs/CLOs/CDMOs; collaborate efficiently within QC/QA to enable timely release and supply of products;
Deviations, investigations
Support, in partnership with internal cross-functional teams, QC quality events, such as change controls, deviations, adverse stability trends, OOS/OOT/OOE investigations, root cause analysis, and CAPAs;
Presenting findings related to QC data to senior management, highlighting trends, issues, and opportunities for improvement;
Data reporting and interpretation
Providing technical input to study reports and regulatory submissions to help insure accuracy of the data reported as well as accurate interpretations
Qualifications & Skills
Advanced degree (PhD or MSc) in Life Sciences or equivalent experience;
8+ years of analytical and/or quality control experience in a clinical and commercial Biotech and/or Pharmaceutical company under GMP environment
Strong experience with data management, data management strategies
Strong experience with working with CLOs/CDMOs, and experience with obtaining (QC) data from external sources
Experience with analytical methods related to cell & gene therapy products
Strong knowledge in QC principles, concepts, industry practices, and standards, including extensive knowledge of cGMP regulations and guidelines;
Strong knowledge and hands-on experience in regulatory requirements and guidelines (ICH/FDA/EMA/USP/Ph. Eur.);
Skilled in the performance of investigations and root cause analysis
Excellent communication, both written and verbal, and interpersonal skills;
Works independently with minimal supervision and is highly collaborative with other groups;
Strong attention to detail and results driven in line with project and team objectives;
This is a hybrid position and uniQure’s office is located in Lexington, MA. We are looking for someone that will be onsite in Lexington a minimum of 3 days per week. Some travel may be required, either to visit (technical visits, audit support) various CLO’s (US, Europe), or for face-to-face communication purposes (uniQure site in Amsterdam).
Seniority level Director
Employment type Full-time
Job function Quality Assurance
Industries Biotechnology Research and Pharmaceutical Manufacturing
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Associate Director, QC Data Management
role at
uniQure
uniQure is dedicated to bringing innovative therapies or 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.
The Associate Director, QC Data Management will play a pivotal role in the advancement of uniQure’s gene therapy pipeline and be responsible for overseeing processes related to QC data management for the various (AAV-based) products, throughout their development phases, both clinical and commercial.
Primary responsibilities include: (1) developing and maintaining a data management strategy and enhancing overall control over data integrity and reliability, leading and mentoring QC analysts and other data professionals; (2) generating and maintaining data overviews per program, and implementing/utilizing data analysis techniques to identify trends and anomalies, as well as signal a need for action; (3) providing oversight and technical input to support closure of any deviations and/or OOS’s related to QC testing, and working with QA to help enable timely release and supply of products; (4) technical review of documentation summarizing/utilizing QC data.
The position requires a keen interest in product data/product quality and strong problem-solving capabilities, helping to address quality issues that can lead to operational inefficiencies/delays and/or financial loss, including having the technical background to fully understand the analytical methods used to generate the data. The position also requires strong collaborative skills, and mentoring/guiding skills working within QC and across departments to ensure (data) quality standards are met and governance principles are followed throughout the organization.
Responsibilities
Developing/continuously improving the overall data management strategy within the context of an outsourcing model (testing performed by CLOs);
Working within uniQure with data integrity & reliability experts, providing a framework/approach both for internal and external QC activities related to data generation/acquisition & data reporting;
Mentoring on data management within QC as well as within the larger TOQ organization;
Data overviews, cross-departmental communication, supporting timely release of products
Gathering program specific data into data overviews that are maintained for communication purposes as well as being a (controlled) basis for study reports and (regulatory) submissions;
Partnering with internal and external teams to meet timelines and company objectives, including internally with Non-clinical Development, Product Development (AD/DSD/DPD), Quality Assurance, Regulatory, and externally with CROs/CLOs/CDMOs; collaborate efficiently within QC/QA to enable timely release and supply of products;
Deviations, investigations
Support, in partnership with internal cross-functional teams, QC quality events, such as change controls, deviations, adverse stability trends, OOS/OOT/OOE investigations, root cause analysis, and CAPAs;
Presenting findings related to QC data to senior management, highlighting trends, issues, and opportunities for improvement;
Data reporting and interpretation
Providing technical input to study reports and regulatory submissions to help insure accuracy of the data reported as well as accurate interpretations
Qualifications & Skills
Advanced degree (PhD or MSc) in Life Sciences or equivalent experience;
8+ years of analytical and/or quality control experience in a clinical and commercial Biotech and/or Pharmaceutical company under GMP environment
Strong experience with data management, data management strategies
Strong experience with working with CLOs/CDMOs, and experience with obtaining (QC) data from external sources
Experience with analytical methods related to cell & gene therapy products
Strong knowledge in QC principles, concepts, industry practices, and standards, including extensive knowledge of cGMP regulations and guidelines;
Strong knowledge and hands-on experience in regulatory requirements and guidelines (ICH/FDA/EMA/USP/Ph. Eur.);
Skilled in the performance of investigations and root cause analysis
Excellent communication, both written and verbal, and interpersonal skills;
Works independently with minimal supervision and is highly collaborative with other groups;
Strong attention to detail and results driven in line with project and team objectives;
This is a hybrid position and uniQure’s office is located in Lexington, MA. We are looking for someone that will be onsite in Lexington a minimum of 3 days per week. Some travel may be required, either to visit (technical visits, audit support) various CLO’s (US, Europe), or for face-to-face communication purposes (uniQure site in Amsterdam).
Seniority level Director
Employment type Full-time
Job function Quality Assurance
Industries Biotechnology Research and Pharmaceutical Manufacturing
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