Vacancy caducado!
Job Description
The Associate Director, R&D Quality Assurance (QA) will support the organization by providing GCP/GVP/GCLP/GLP QA oversight for research and development activities required at all stages of Unum’s products’ life cycle. In this position, the incumbent will be actively involved in executing the R&D QA strategy by participating in R&D program teams, contributing to risk-based assessments, providing R&D QA support to foster cross-functional partnerships, and implementing regulatory intelligence processes. This role will be involved in review of MAA/BLA submissions, contribute to inspection readiness efforts and Quality Management System (QMS) activities including procedural development, metrics tracking, and other process improvements. Additionally, the Associate Director, R&D QA will lead and manage quality with external CDMOs, oversee execution of GMP/GCP and internal audit plans, review reports and track corrective actions
What You’ll Do
Lead the R&D QA Strategy implementation
Represent R&D QA at program team meetings
Perform R&D QA risk assessments
Build and foster cross-functional partnerships throughout the organization
Review IND submissions and other R&D submission documentation
Lead delegated GCP/GVP/GCLP/GLP Inspection Readiness efforts
Provide procedural development and other process improvements. Where there is cross-reference and/or cross functionality with other bluebird bio functional controlled procedures, ensure harmonization for alignment and compliance
Perform GCP/GVP/GCLP/GLP metrics tracking and reporting
Own, facilitate and oversee audits, deviations and CAPAs
Serve as the primary point of contact for R&D QA controlled documents (i.e. SOPs, WIs, etc.) and R&D QA training and as the subject matter expert for these topics during audits and inspections
Monitor GCP/GCLP/GVP/GLP non-conformance trends and communicate this information to management with proposed remediation actions
Contribute to commercial readiness preparations internally and at GMP vendors
Lead R&D QA activities during preparation, conduct, and follow-up for Regulatory Agency inspections and internal audits
Manage the development, review and approval of lifecycle validation master plans, protocols and reports working with CDMOs
Track GCP/GCLP/GVP/GLP commitments from internal audits, regulatory inspection findings, CAPAs and other regulatory commitments
Provide project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks
Support GCP/GCLP/GVP/GLP compliance and alliance activities with vendors and business partners and lead Quality Agreement creation and revision
Qualifications
Bachelor’s Degree or equivalent work experience in a scientific or technical discipline
Must have a minimum of 10 years of experience in the areas of GXP regulations with a minimum of 7 years of experience in a GMP, GCP or GVP quality and compliance role
Quality and compliance background, preferably related to GMP/GCP/GVP
Demonstrated analytical and process skills
Effective communication, consulting, customer service and problem-solving skills
Must be detail oriented, capability to meet deadlines
Strong interpersonal skills and ability to interact with all levels of the organization
Additional Information
Where are we?
Unum is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration and state-of-the-art laboratories. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.
What do we offer you?
To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), unlimited time-off, a 401(k) plan, and commuter/parking benefits.
- Unum is an equal opportunity employer
- Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals
Vacancy caducado!