Associate Director, Quality Sterility Assurance and Aseptic Controls - Boston, United States - Vertex Pharmaceuticals, Inc

Description

Job Description


GENERAL POSITION SUMMARY

The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing.

This role will partner with stakeholders to define strategies for microbial control activities in key areas that include facility and equipment design and qualification (e.g. cleanroom, isolators, autoclaves, etc.), environmental qualification and monitoring programs, and operational practices (e.g. gowning, cleaning and sanitization, etc.).

This individual will interface with internal and external manufacturing sites to support the maintenance of critical cGMP aseptic activities and provide technical support for the overall contamination strategy and facility monitoring programs.

The incumbent will work cross-functionally with colleagues from Manufacturing, Manufacturing Science and Technology, Global Engineering, Validation, Process Engineering, EM/UM Quality Control, CMC Regulatory, and Quality Operations on the design of processes and technologies required to produce aseptic drug product to successfully commercialize an exciting and diverse portfolio of innovative cell and gene therapy pipeline programs.

In addition, the successful candidate will be experienced in the fields of aseptic process technologies, microbial testing, environment and critical utilities monitoring programs, and in the design, commissioning, and qualification of facilities, utilities, and equipment systems.

This role will report to the Director of Quality Validation and Engineering within the Vertex Cell and Genetics Therapies QA group.

KEY DUTIES AND RESPONSIBILITIES
Sterility Assurance and Aseptic Controls

• Provide quality oversight and technical support across all project phases from design, commissioning, and qualification of cGMP manufacturing facility startups, manufacturing systems, critical utilities, and analytical instruments in support of aseptic manufacturing of cell and gene clinical and commercial products.
• Support environmental qualifications for cleanrooms, isolators, and biosafety cabinets. Additionally, support the qualification of autoclave systems, disinfectant efficacy studies.
• Support the design and implementation of risk-based approaches and strategies designed to control bioburden and prevent contaminations in cell-based processes for drug substance and drug product manufacturing sites.
• Provide quality oversight of the environmental and utilities monitoring programs for Vertex CGT facilities, technical input into environmental/facility monitoring program excursions and identified trends, and contamination events to determine impact to batch disposition.
• Provide SME support for sterility assurance and aseptic controls related investigations including support the design and implementation of effective corrective and preventative actions to prevent future recurrence.
• Responsible for review and approval of EM and UM program trending reports.
• Provide analytical testing strategies for environmental viable and non-viable testing and associated methods.
• Work closely with business colleagues to design and implement new technologies for aseptic filling of cell therapy drug products in novel device platforms; this includes working closely with Contract Development and Manufacturing Organizations (CDMOs) and engineering firms to design processes and equipment needed to perform aseptic filling operations in a GMP environment.

Operations - Facilities, Validation, and Engineering Support

• Collaborate with internal and external (CDMO) project teams and provide QA support for assigned CAPEX and OPEX projects. Project scopes may include large projects to design, construction, fit out, qualification and startup of new facilities for the manufacturing, testing, and or storage of cell and gene therapy products.
• Responsible to support all project phases from conceptual design, through commissioning and qualification for GMP release.
• Support validation maintenance program including the review and approval of periodic assessments and requalification activities.
• Provide oversight for various facility control programs that include facilities and equipment maintenance and calibration program, qualified system monitoring and alarm system (EMS), and facility pest control program, including the review and approval of associated trend reports.
• Support annual plant shutdown and other planned area shutdown activities, including providing guidance on containment and other controls to minimize impact on cleanroom spaces, provide technical support and strategy for return to service cleaning, testing, and GMP release of the facility.
• Serves as QA document approver for processes/programs in the Facilities, Validation and Engineering spaces and responsible for identifying risks, communicating gaps, and driving mitigations and process improvements to address.

Audit / Inspection Support

• Serves as quality subject matter expert (SME) for aseptic and facility control programs in scope of responsibilities outlined in this job description along with the associated validation lifecycle elements.
• Participate in inspection readiness activities and provide support during regulatory site inspections. Provide post inspection support to address any regulatory observations.

Deployment of QMS and Establishment of Compliance Expectations

• Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.
• Reviewer and/or approver of SOPs and Work Instructions as assigned.
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issues in a timely manner.
• Contribute to the design, development and implementation of GMP topic specific training program.

REQUIRED EDUCATION AND EXPERIENCE

• Demonstrated aptitude for facilitating group or project team endeavors and building team unity
• Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process
• Demonstrated ability to work independently to provide QA support for large, multifaceted projects
• Experience in an aseptic drug product technical role in process development and/or manufacturing for biologics and/or cell therapy products and demonstrated ability to implement industry-recognized best practices and risk-based approaches for sterility assurance and contamination control and prevention.
• Deep understanding of technical and operational aspects of late phase to commercial GMP aseptically processed drug substance and drug product manufacturing regulations and excellent written and verbal communication skills. Prior experience supporting aseptic drug product manufacturing activities across multiple modalities (e.g., sterile dosage form, devices, etc.) and design of sterility assurance and facility monitoring programs is desired.
• Demonstrate technical expertise to define approaches and execution of system validation activities in accordance with cGMP, cGxP, CFR 21 Parts 11, 210, 211, ICH Q7, Q8, Q9 and applicable regulations and industry standard procedures.
• Experience with qualification of manufacturing equipment, laboratory instrument, and facility and utility system in a cGMP setting.
• Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
• Experience with system automation, and network-based applications such as Oracle and Veeva preferred.
• Advanced degree (PhD or equivalent) in biological (microbiology preference) and/or engineering disciplines with minimally 10 years of relevant experience in biotech or pharmaceutical industries, ideally in a technical leadership role in a cGMP facility

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Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at