Change Control Process Manager - Quality Assurance MFX

DESCRIPTION OF THE COMPANY

Tissium is a missiondriven medical device company founded in 2013 headquartered in Paris with a production facility in Roncq (near Lille) and an office in Boston. We are dedicated to creating a new era of body repair by leveraging our biopolymer platform to develop new innovative solutions in surgery for a positive impact on patients lives.

Tissiums technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Womens Hospital) who cofounded the company with Christophe Bancel (CEO) and Maria Pereira (Chief Innovation Officer).

We are developing polymers for atraumatic tissue repair in various applications. Today these polymers are used for structureless nerve repair hernia repair and cardiovascular sealing

Since our inception we have raised a total of 170 million euros. Our latest fundraising round which concluded in April 2023 resulted in 50 million euros in additional funding. This infusion of capital provides us with the necessary resources to finance the commercialization of our first products.

RESPONSIBILITIES

We are seeking a motivated individual to join our growing team as a Change Control Process Manager.

The Quality Assurance Specialist Change Control Process Manager is responsible for managing change controls related to manufacturing product process equipment and facility contributing to the oversight of key strategic tactical and operational aspects within Quality Assurance. This newly created position has the opportunity to engage in a variety of projects at various stages of development but primarily focuses on Phase 3 and commercial Quality Assurance through the direct project management of varying complexities of change controls initiated for the GMP operations in our manufacturing facility.

Under the guidance and direction of the Quality Director essential functions of the Quality Assurance Change Control Process Manager include at a minimum:

• Review/Initiate/Manage local and Global Change Controls and associated activities for our production site.
• Supporting Regulatory Agency submissions and audits by being a SubjectMatter Expert in the assigned area.
• Review and audit complex documents: batch records GMP protocols process and method validations.
• Assist with reviewing CMO authored Annual Product Reviews/Product Quality Review and Process Change Control Metrics as assigned.
• Manage QMS; author review and approve SOPs and Policies for our productionfacility.
• Observe manufacturing activities to support implementation of best practices and improvements.
• Prepare routine updates and project status report of Quality Assurance activities.
• Communicate quality metrics client production tracking and metrics and quality improvement initiatives to senior leadership.
• Provides oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
• Ensures that documentation is maintained in accordance with internal procedures and regulatory requirements.
• Supports prepares provides Quality training with crossfunctional teams as assigned.
• Supports and maintains an environment that fosters communication and teamwork within Quality Assurance and related departments.

The employee shall apply all regulatory requirements in place at Tissium by applying Tissium Quality Management System documentation.

REPORTING LINE

This job will report to the Quality Director.

YOU WILL LOVE THIS JOB IF

• You have demonstrated project management abilities with experience managing several projects meeting deadlines and using critical thinking skills to problemsolve effectively.
• You possess excellent verbal and written communication skills. Technical writing required.
• You have strong experience as an individual contributor working in crossfunctional teams. Ability to influence negotiate manage conflict and collaborate.
• You have a cando attitude.

YOUR BACKGROUND

• Minimum of 23 years experience in GMP/Biopharmaceutical/Biotech Industry medical device experience preferred; change control experience a must.
• Bachelors Degree in a technical or scientific discipline or equivalent.
• Proficient knowledge of GMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 210 & 211
• Experience in commercial and clinical GMP production and ability to provide QA support for both.
• Knowledge of FDA regulations European Directives ICH guidelines and GMP regulations regulatory inspection experience preferred.

WHY JOIN US

• A work culture that values urgency a willingness to take risks a desire to learn an ability to challenge norms and a capacity to operate within a dynamic range;
• A competitive salary;
• 50% reimbursement of transportation expenses;
• The flexibility to work in Paris Roncq or a hybrid arrangement;
• An international work environment with team members from over 13 different nationalities reflecting Tissiums commitment to diversity and its inherent strengths;
• An opportunity to join an ambitious startup striving to address one of the most persistent medical challenges since the inception of surgical procedures.

HIRING PROCESS

• The journey starts with an interview with Talent Acquisition Manager (30 mins)
• Then a facetoface (virtual) meeting with the Manager of the department you are applying to join (1 hour)
• This will then be followed by a case study or business case to validate your practical jobrelated skills (1 hour)
• For the very final round you will meet other teams in Tissium
• You will be asked to provide us with professional references including contact details.

Intrigued Wed love to hear from you! Apply today were standing by for your resume!

We firmly believe that building a company for everyone requires a diverse team. Our organization values diversity and welcomes applications from individuals of all backgrounds. We do not discriminate against employees or applicants based on gender identity or expression sexual orientation race religion age national origin citizenship disability pregnancy status veteran status or any other differences. Our company culture prioritizes human interaction and ensures that every individuals voice is heard making our processes lightweight yet efficient.