Sr. Manager, Quality (GCP)
About Us:
We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases.
At Larimar, we embrace everyone's contribution to our Mission.
Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate.
If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you!Position
Summary:
The Sr.
Manager, Quality (GCP) will support the Quality organization at Larimar, executing GCP QA activities related to clinical product development and clinical studies.
This position will interact cross-functionally to provide GCP and compliance support for ongoing and new clinical studies led by the Larimar Clinical team.
This position will also assist with management of internal quality systems and processes while ensuring compliance with Larimar requirements as well as US and EU GCP regulations and guidelines.
The Sr.
Manager, Quality (GCP) works with all members of the Quality team, including relevant internal contractors, to ensure quality compliance internally and among the company's contractors, CROs, service providers, etc.
to enable development, regulatory approval, and commercialization of the company's products.
This role reports to the Director, Quality.
Responsibilities:
Will include but are not limited to:
Providing GCP Quality oversight and support cross-functionally and to Larimar's CROs.
Attending study team meetings and providing guidance on quality issues, as needed.
Working closely with internal colleagues to develop systems and processes in-line with regulatory requirements, GCP and internal quality processes, as required.
Collaborating with Quality representatives at Larimar's CROs and vendors to ensure the appropriate Quality Agreements and Plans have been developed and implemented in support of the study.
Conducting QA review of clinical protocols, ICFs, other clinical trial specific documents and associated data.
Leading the quality and clinical operational meetings to discuss the status of audits, planned audits, and outstanding CAPAs.
Planning, scheduling, and conducting/participating in audits of Clinical Investigator Sites, Suppliers/Vendors, TMF, and Clinical submission documents to evaluate processes, systems, and procedures for compliance to GCP and Larimar requirements.
Leading inspection readiness preparation internally and with suppliers and clinical sites, as applicable.
Working cross-functionally with stakeholders across the business to support the escalation and management of Deviations, Corrective and Preventive Actions (CAPA), Investigations, as well as other issues impacting business processes.
Assisting in establishing processes to ensure Data Integrity and communicate principles of data integrity for GCP.
Supporting the development and/or revision of Quality and Clinical processes and procedures including SOPs and risk assessment tools.
Conducting GCP training for Larimar staff.
Supporting quality system monitoring reviews.
Assisting in compiling information for regulatory submissions and conducting quality reviews and auditing of regulatory submissions, as requested.
Supporting other Quality activities, as required.
Approximately 10-15% travel required.
Education, Experience, Skills, and Knowledge:
This role requires a Bachelors degree, a minimum of 5-8 years of experience in a Quality role in the biotechnology industry with a minimum of 2 years experience performing GCP audits of investigator sites and/or CROs or comparable GxP audit experience.
An understanding of GxP systems and quality principles, and the ability to understand GCP regulations (FDA, MHRA, EMA, etc.
) and guidance documents (GCP/ICH) and translate understanding to practice is also required.
Experience with hosting GCP regulatory inspections is preferred.
The successful candidate will possess a strong attention to detail while having the ability to set priorities and meet aggressive timelines.
The successful candidate will also have the ability to work with business leads in a supportive role, with a thorough understanding of Excel, Microsoft Project, and document management systems.
PI225478043 Recommended Skills Attention To Detail Auditing Biotechnology Business Processes Clinical Works Corrective And Preventive Action (Capa) Estimated Salary: $20 to $28 per hour based on qualifications.
We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases.
At Larimar, we embrace everyone's contribution to our Mission.
Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate.
If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you!Position
Summary:
The Sr.
Manager, Quality (GCP) will support the Quality organization at Larimar, executing GCP QA activities related to clinical product development and clinical studies.
This position will interact cross-functionally to provide GCP and compliance support for ongoing and new clinical studies led by the Larimar Clinical team.
This position will also assist with management of internal quality systems and processes while ensuring compliance with Larimar requirements as well as US and EU GCP regulations and guidelines.
The Sr.
Manager, Quality (GCP) works with all members of the Quality team, including relevant internal contractors, to ensure quality compliance internally and among the company's contractors, CROs, service providers, etc.
to enable development, regulatory approval, and commercialization of the company's products.
This role reports to the Director, Quality.
Responsibilities:
Will include but are not limited to:
Providing GCP Quality oversight and support cross-functionally and to Larimar's CROs.
Attending study team meetings and providing guidance on quality issues, as needed.
Working closely with internal colleagues to develop systems and processes in-line with regulatory requirements, GCP and internal quality processes, as required.
Collaborating with Quality representatives at Larimar's CROs and vendors to ensure the appropriate Quality Agreements and Plans have been developed and implemented in support of the study.
Conducting QA review of clinical protocols, ICFs, other clinical trial specific documents and associated data.
Leading the quality and clinical operational meetings to discuss the status of audits, planned audits, and outstanding CAPAs.
Planning, scheduling, and conducting/participating in audits of Clinical Investigator Sites, Suppliers/Vendors, TMF, and Clinical submission documents to evaluate processes, systems, and procedures for compliance to GCP and Larimar requirements.
Leading inspection readiness preparation internally and with suppliers and clinical sites, as applicable.
Working cross-functionally with stakeholders across the business to support the escalation and management of Deviations, Corrective and Preventive Actions (CAPA), Investigations, as well as other issues impacting business processes.
Assisting in establishing processes to ensure Data Integrity and communicate principles of data integrity for GCP.
Supporting the development and/or revision of Quality and Clinical processes and procedures including SOPs and risk assessment tools.
Conducting GCP training for Larimar staff.
Supporting quality system monitoring reviews.
Assisting in compiling information for regulatory submissions and conducting quality reviews and auditing of regulatory submissions, as requested.
Supporting other Quality activities, as required.
Approximately 10-15% travel required.
Education, Experience, Skills, and Knowledge:
This role requires a Bachelors degree, a minimum of 5-8 years of experience in a Quality role in the biotechnology industry with a minimum of 2 years experience performing GCP audits of investigator sites and/or CROs or comparable GxP audit experience.
An understanding of GxP systems and quality principles, and the ability to understand GCP regulations (FDA, MHRA, EMA, etc.
) and guidance documents (GCP/ICH) and translate understanding to practice is also required.
Experience with hosting GCP regulatory inspections is preferred.
The successful candidate will possess a strong attention to detail while having the ability to set priorities and meet aggressive timelines.
The successful candidate will also have the ability to work with business leads in a supportive role, with a thorough understanding of Excel, Microsoft Project, and document management systems.
PI225478043 Recommended Skills Attention To Detail Auditing Biotechnology Business Processes Clinical Works Corrective And Preventive Action (Capa) Estimated Salary: $20 to $28 per hour based on qualifications.
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