Address
Form of workJob Description
Job Description
The Role:
Reporting to the Director of R&D Vendor Quality within Research & Development Quality (RDQ), located at the *** Headquarters in Cambridge, MA, the contingent Manager will (i) Work with the RDQ and stakeholders to provide Quality support for *** s R&D Quality vendor program and drive continuous improvement of clinical, non-clinical and pharmacovigilance services to the *** R&D organization. You will work with internal business partners and alignment with business expectations, GxP standards and other applicable regulatory requirements. The Manager will also partner with R&D to create a quality culture within ***.
Here s What You ll Do:
Support strategic initiatives by leading projects to design and deploy process and technology related improvements and monitoring of R&D vendor issues for trends across the operational areas
Develop and write vendor issue procedures
Support in developing establishing metrics and KPIs for R&D vendor issues
Define and develop quality agreement process with R&D vendors
Process vendor requests
Quality checks of Vendor Quality documents
May participate in GCP, GLP, or GVP audits
Here s What You ll Bring to the Table:
BS/BA in life sciences and a minimum of 6-8 experience in Biotech, Pharma or Vaccine Industry
Working knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GCP regulations, guidelines and local legislation
Auditing experience in GCP, GLP, or GVP preferred
Excellent communication skills
Strong interpersonal skills and ability to effectively interact with all levels with the organization
Ability to work independently and within a team environment
Ability to manage multiple projects in a fast-paced environment
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
The Role:
Reporting to the Director of R&D Vendor Quality within Research & Development Quality (RDQ), located at the *** Headquarters in Cambridge, MA, the contingent Manager will (i) Work with the RDQ and stakeholders to provide Quality support for *** s R&D Quality vendor program and drive continuous improvement of clinical, non-clinical and pharmacovigilance services to the *** R&D organization. You will work with internal business partners and alignment with business expectations, GxP standards and other applicable regulatory requirements. The Manager will also partner with R&D to create a quality culture within ***.
Here s What You ll Do:
Support strategic initiatives by leading projects to design and deploy process and technology related improvements and monitoring of R&D vendor issues for trends across the operational areas
Develop and write vendor issue procedures
Support in developing establishing metrics and KPIs for R&D vendor issues
Define and develop quality agreement process with R&D vendors
Process vendor requests
Quality checks of Vendor Quality documents
May participate in GCP, GLP, or GVP audits
Here s What You ll Bring to the Table:
BS/BA in life sciences and a minimum of 6-8 experience in Biotech, Pharma or Vaccine Industry
Working knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GCP regulations, guidelines and local legislation
Auditing experience in GCP, GLP, or GVP preferred
Excellent communication skills
Strong interpersonal skills and ability to effectively interact with all levels with the organization
Ability to work independently and within a team environment
Ability to manage multiple projects in a fast-paced environment
Ability to collaborate effectively in a dynamic, cross-functional matrix environment
