Senior Manager, Quality Control

Position Purpose:

The Sr. Manager, Quality Control (QC) is responsible for overseeing all aspects of GMP testing and supporting stability program management for Stoke’ IMPs at Stoke’s Contract Testing Laboratories (CTLs) / Contract Manufacturing Organizations (CMOs). In this role, this person is accountable for ensuring that Stoke’s product stability programs are successfully designed, implemented and executed at CTLs to support product shelf-life for clinical use. This individual will also lead stability transfers of products including sample chain of custody for both stability and routinely manufactured products, sample management, protocol design, implementation, analysis, reporting, and trending. This person will support Stoke’s CMC team with analytical method transfers and validation to and at Stoke CTLs / CMOs. This person will also be a key contributor to maturing and shaping Stoke’s internal GMP quality processes for QC laboratory controls and is responsible for supporting Stoke’s CMC Manufacturing and Analytical Development teams towards ensuring compliance with regulations (e.g., FDA, EMA, etc.). The Sr. Manager, QC is accountable for regulatory inspection interactions related to analytical method validation and product testing. This individual will oversee the deployment of strategy for analytical method development / transfer and validation for Stoke’s products, specifications development as well as QC for GMP testing across Stoke’s CTL / CMO network. Other functions for this role include oversight of laboratory investigations related to product testing; review and approval of test results, annual reports, and technical reports; and authoring and review of CMC analytical sections of regulatory submissions. 

Key Responsibilities:

• Establish and maintain QC SOPs for GMP testing, laboratory controls, analytical method qualification /validation, reference standard management and stability management to meet ICH, FDA, and EMA regulations.
• Oversee day-to-day management of outsourced GMP release testing at various CTLs / CMOs to ensure successful and compliant execution of laboratory operations to meet GMPs, regulatory requirements, guidelines, internal policies, and procedures.
• Evaluate the sample size requirement for functional testing of medical devices for release and stability

• Use scientific expertise to aid CMC in troubleshooting analytical compliance issues and resolution.

• Provide QC oversight for method transfers, method qualification and validation.
• Review and approve analytical documentation generated at CTLs / CMOs, including specifications, analytical method validation protocols/reports and CoAs.
• Evaluate data to detect product or method-related trends. Write periodic trend summaries.
• Contribute to the preparation and review of analytical sections of CMC for regulatory submissions and annual reports.
• Review and approve laboratory investigations related to release and stability testing performed on GMP samples. Ensure that records and technical data are accurately maintained and results well documented.
• Support the product stability program, including compliance with policies and practices for stability protocol execution; review of stability data; review for potential trends to ensure compliance with regulations.
• Represent QA / QC on project teams, as needed and provide GMP compliance interpretation, consultation, and other supportive services necessary to maintain and improve compliance to ensure product quality, data integrity and patient safety.
• Assist audits of laboratories, as necessary, and work with Stoke staff to ensure the implementation of appropriate CAPAs.
• Provide GMP compliance technical support during regulatory inspections at Stoke’s CTLs / CMOs as necessary
• Provide input to and review of responses to regulatory agency questions resulting from regulatory inspections.
• Contribute to the development of Stoke’s Quality culture.

Required Skills & Experience:

• B.S. in Biochemistry, Chemistry, Biology, Pharmaceuticals or equivalent with a minimum of 8+ years’ combined experience in biopharmaceutical product development including Analytical Method Development, qualification / validation and transfer of methods to CTL’s.
• Minimum of 3+ years of experience in analytical method development and validation for devise including pre-filled syringes
• Fully versed in GMPs, ICH Guidelines, FDA, and other regulatory agency requirements related to laboratory functions.
• Operational QC experience with experience providing Quality support and oversight of GMP laboratory operations at CTLs / CMOs for product release testing.
• Attention to detail with the ability to work within a multi-disciplinary team, as well as with external partners and vendors to establish and maintain a strong quality relationship.
• Familiar with the use of electronic document management, laboratory information management and statistical analysis techniques.
• Ability to work autonomously, provide QC advice, effectively manage time, and deliver results on time.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Desired Experience, Knowledge, Skills:

• Advanced Degree in Science (M.S. or Ph.D.)
• Strong experience with GMP laboratory management with specific experience in writing regulatory submissions (IND, IMPD, NDA, MAA) and supporting regulatory inspections.
• Hand-on experience for analytical methods used for pre-filled syringes
• Strong verbal and written communication skills.
• Ability to manage multiple projects in a fast-paced environment.
• Excellent organizational, interpersonal, verbal, and written communication skills.
• Conflict resolution/management and negotiation skills.

Location(s):

Stoke is located in Bedford, MA.  This position is a hybrid position with an office based in Bedford, MA location.

Travel:

This position will require approximately 15% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $172,000 - $192,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).