Manager, IT Validation

Job Details

The Organization
What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.
The Perfect Addition to Our Team
You are driven and enthusiastic. You thrive in a fast-paced collaborative environment and can manage multiple projects concurrently. You are detail-oriented and able to review and analyze quality issues quickly to provide robust and timely solutions.

You have strong knowledge of relevant compliance regulations, extensive experience with system validation, and familiarity with various systems like EDMS, LIMS, and ERP, along with experience in regulatory inspections and the ability to collaborate effectively.

You are dependable and accountable for your work. You are able to lead teams and develop strategies while not being afraid to roll up your sleeves and review clinical trial specific documents and GLP reports.

You are an excellent team player and relationship builder. You know when to step in and lead something and when to offer your support. You excel at building relationships and trust with your key stakeholders.
The Opportunity
The Manager, IT Validation, will report directly to the Head of Information Technology. The ideal candidate will manage computer system qualification and validation activities. This position will ensure the quality and compliance of Entrada's computer systems and electronic infrastructure. This individual will ensure that all IT systems are validated, compliant with regulatory requirements (such as FDA 21 CFR Part 11, GxP, ICHE6 (R3), and other industry standards), and fit for purpose to support manufacturing, product development, and commercialization processes. The Manager, IT Validation will provide leadership in the design, execution, and documentation of IT validation strategies while working cross-functionally with IT, Quality Assurance, Regulatory Affairs, and other departments.
Responsibilities
IT Validation Strategy and Planning:

• Support the design and development of Entrada's IT validation strategy and be responsible for its execution, ensuring alignment with regulatory requirements and business objectives, ultimately leading and managing these efforts.
• Develop comprehensive IT validation plans for new and existing systems, ensuring alignment with the company's commercialization roadmap.
• Define appropriate validation methodologies for different types of IT systems, software applications, and infrastructure.
• Oversee the scheduling and coordinate with cross functional team members to meet project deadlines.

Compliance and Regulatory Adherence:

• Lead efforts to ensure IT systems meet compliance requirements including GxP (Good Automated Manufacturing Practice), FDA 21 CFR Part 11, EU Annex 11, ICHE6 (R3) and other relevant regulations.
• Prepare for internal and external audits, ensuring all validation documentation is ready and up to date.
• Oversee the creation, review, and approval of validation documentation, including Validation Master Plans (VMP), User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and other system-specific documents.
• Monitor and track compliance with internal validation procedures and regulatory guidelines throughout the product lifecycle and will be responsible for developing and delivering training materials to educate personnel on relevant policies and procedures.

User Access Oversight and Provisioning:

• Establish and maintain processes for user account creation, modification, and termination across relevant IT systems, ensuring adherence to security policies and regulatory requirements.
• Conduct regular reviews of user access rights and permissions to verify appropriateness and implement necessary adjustments or revocations based on job roles and responsibilities.
• Maintain accurate and up-to-date documentation of user access provisioning activities, including approvals and audit trails, to support compliance and security audits.

System Validation and Vendor Management:

• Oversee the validation of critical IT systems, including software and hardware, ensuring they are fit for purpose through the supervision and coordination of IQ, OQ, PQ testing and other required validation activities.
• Implement and manage a robust change control process for validated systems and oversee the qualification and management of third-party vendors involved in IT validation to ensure compliance with company standards and regulatory requirements.
• Coordinate with procurement and legal departments to manage contracts related to validation services, ensuring vendor adherence to regulatory obligations.

Cross-Functional Collaboration and Leadership:

• Work closely with IT infrastructure teams, quality assurance teams, and project management teams to ensure smooth integration of validated IT systems into operational environments.
• Serve as a primary point of contact for all IT validation-related matters, providing clear communication between internal and external stakeholders.
• Manage IT validation projects, tracking timelines, budgets, and resources while ensuring all deliverables are met on time.

The Necessities
At Entrada, our passion for science, our devotion to patients and our values drives our behavior:

• Humanity - We genuinely care about patients and about one another.
• Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
• Creativity - We are creative problem solvers.
• Collaboration - We are more than the sum of our parts.
• Curiosity - We have a growth mindset and push conventional thought and theory.

To thrive on our team, you will need to come with:

• BS in computer science or scientific discipline, advanced degree preferred with at least 10 years of experience in pharmaceutical / biotech / clinical research industry with significant experience in IT, regulated GxP pharma, and lab environments.
• Strong knowledge of 21 CFR Part 11, Annex 11, GAMP 5, DSCSA, CSA, ICHE6 (R3) and GDPR compliance.
• Extensive experience with electronic infrastructure and computer system qualification and validation.
• Highly proficient with various system types such as Electronic Documentation Management Systems (EDMS), Laboratory Information Management Systems (LIMS), and Enterprise Resource Planning (ERP) systems.
• Experience assessing software validation and software as a service (SaaS) system(s).
• Proficient in preparing for and participating in regulatory inspections.
• Ability to collaborate effectively with stakeholders and cross-functional teams across various departments
• Skilled in managing tasks independently while maintaining strong organization.
• Strong ability to create practical and efficient processes.
• Ability to make decisions based on company and/or quality policies and procedures.
• This position is an on-site role, with an expectation of 5 days per week in our Boston, MA office.

The Perks
By becoming a team member here at Entrada, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.
Third Party Staffing Agencies
Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.
Privacy Statement
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