This is an exciting new role in a rapidly growing contract manufacturing organization. As Principal - 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.
How You Will Make an Impact:- 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
- Experience with the technical transfer process and working within a multi-product manufacturing facility. CMO experience is desirable.
- 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
What You Will Bring:- 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;
Qualifications:- Minimum of 10 years of experience in GMP Quality in biologics industry required
- Experience with advanced therapeutic modalities such as cell therapy is desired
- University degree in life sciences or related fields is required
Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.
At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.
Department Quality Assurance Locations Hopkinton Yearly salary $120,000 - $180,000 Employment type Full-time
