Product Quality Lead

RoslinCT US • Hopkinton, MA

1d • $120,000 - $180,000

About The Position

This is an exciting new role in a rapidly growing contract manufacturing organization. As a Product Quality Lead, you will represent Quality Assurance on project teams and provide product quality oversight from new product introduction through to commercial manufacture in a multi-product manufacturing facility. This requires a solid understanding of technical transfer methodology, GMP and product lifecycle requirements. This is a client facing role so strong verbal and written communication skills is required.

Requirements

• Thorough knowledge of GMP regulations is required (FDA and EMA); direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus; direct interaction with EU Qualified Person (QP) is a plus;
• Experience supporting early development and all clinical phases through commercialization and lifecycle management
• Proficiency in electronic QMS Software
• Excellent attention to detail, organizational and time management skills;
• Must have strong written and oral communication skills;
• Minimum of 10 years of experience in GMP Quality in biologics industry required
• University degree in life sciences or related fields is required

Nice To Haves

• Experience with the technical transfer process and working within a multi-product manufacturing facility. CMO experience is desirable.
• Experience with advanced therapeutic modalities such as cell therapy is desired

Responsibilities

• Represent Quality Assurance on technical transfer teams to onboard new clients (clinical and commercial) to RoslinCT and provide Quality oversight throughout the product lifecycle.
• Quality Approver for product related change controls
• Review and approve controlled documents (Mfg, QC and QA) in alignment with timeline for engineering and GMP runs.
• Review of IND or BLA sections related to RoslinCT for client submissions
• Establish Quality Agreement with partner company including agreed requirements related to batch disposition, client notifications and escalations.
• Provide Quality Assurance oversight to the project to ensure products manufactured are produced in accordance with regulatory requirements, product registrations
• Conduct and review product and/or lot-related major or critical deviations
• Support client complaints, client requested change controls, and annual product quality reviews (APQRs);
• Partner with QA Operations team to transition new products to routine manufacturing activities.
• Identify new supplier intakes and collaborate with Supplier Qualification to ensure suppliers are onboarded in alignment with the project plan.
• Support client audits, as needed, and inspection preparedness activities
• Demonstrate high level of involvement in continuous improvement of quality assurance practices as they relate to new product introduction/tech transfer
• Participate in developing, reporting, reviewing, and trending of GMP-related Quality Metrics such as Key Performance Indicators (KPIs) in support of the QMS

Benefits

• medical, dental, and vision insurance
• educational assistance
• a 401(k) program
• a variety of additional resources to help you thrive both personally and professionally

What This Job Offers

• Job Type: Full-time
• Career Level: Senior