Job Description:    

Comments:

• Position is hybrid - 50/50 - may fluctuate dependent on site needs.    

• This role is responsible for managing inspection readiness and self-inspection activities for the Devens Cell Therapy Manufacturing Site located in Devens, MA.

• This role will be interacting and supporting CTDO functions at our Devens site from a compliance perspective.

• Specifically, partnering with different functions (i.e. Operations, Supply Chain, MS&T) to proactively identify compliance risks, develop collaborative solutions, and track effective resolution of actions to close compliance gaps.

• Provides assistance in managing the day to day activities related to audits and inspections

• Coordinates and supports audit and inspection logistics at the site (scheduling of activities, planning, issuing agendas, reports etc..)

• Participates actively during inspections and audits, including performing readiness exercises before and during inspections/audits

• Assists in the development, implementation, and maintenance of procedures for the site Compliance programs

• Prepares training materials on GMP Topics, including inspection readiness and audit management

• Assist in development of effective auditing tools and training aids

• Trains SMEs and support staff on specific roles, responsibilities, processes, and systems associated with inspection management and support

• Initiates and coordinates writing and on-time completion of regulatory commitments, responses, and other correspondence

• Collaborates with internal teams on key issues ensuring compliance with cGMP and other regulations

• Identifies compliance risks and escalate issues to appropriate levels of management for resolution

Qualifications:

• Bachelor's degree or higher in life sciences, chemistry, engineering, or related field

• Minimum 5 years of experience

• Must have knowledge and experience with cGMP manufacturing, quality, and compliance as well as US and global cGMP requirements

• Experience with regulatory inspections and internal GMP audits

• Excellent verbal and written communication skills with ability to prepare written communications and communicate problems to management with clarity and accuracy.

• Demonstrates a high degree of attention to detail, with strong documentation expertise. 

• Able to effectively multi-task and demonstrate strong organizational skills.

• Possesses the ability to generate and present audit/quality metrics via PowerPoint/Excel.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Savita Khashu

Email ID: savitak@askconsulting.com

Phone: 470-483-1052