Associate Director/ Senior Manager, Quality

7 days ago


Singapore Tessa Therapeutics Pte Ltd Full time

**Company Background**

Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors.

Tessa’s lead autologous therapy is in late-stage clinical development for treatment of lymphomas. It has shown strong clinical responses in patients with relapsed/refractory classical Hodgkin lymphoma, based on which it was granted the RMAT designation by the U.S. FDA and the PRIME designation by EMA.

Tessa is also developing a novel, differentiated, allogeneic “off-the shelf” cell therapy platform to create more efficacious, reliable, and scalable therapies capable of targeting a broad range of cancers. A therapy using this platform is being evaluated in an ongoing clinical trial in United States.

**Job Position**
Associate Director/ Senior Manager, Quality Assurance (Quality Operations)
- Responsible to lead the Quality Operations team within Tessa Singapore Manufacturing Operations (TSMO) in providing quality oversight in manufacturing, QC, warehouse operations, engineering, validation etc according to applicable current GxP and regulations and to ensure that facilities, equipment, materials, processes and procedures comply with applicable current GxP and regulations.
- Responsible in the review of batch records and ensure lot disposition is performed as per plan.
- This role will also be expected to serve as sterility assurance lead for TSMO and ensuring that the site is in compliance with the regulatory requirements for sterile manufacturing.
- Implements, maintains and reviews the assigned Quality Process according to applicable current GxP and regulations
- Owns policies and procedures of the assigned Quality Process
- Partners with and communicates to functions to ensure the assigned Quality Process is executed according to established policies and procedures
- Reviews/approves and provides inputs for procedures, documents, records, deviations, investigations, corrective action/preventive actions, change controls and gap assessments associated with the assigned Quality Process
- Ensures deviations from assigned Quality Process are documented and investigated
- Ensures QA personnel are qualified and trained to perform assigned tasks
- Develops strategies for assigned Quality Process to ensure a state of inspection readiness
- Supports inspection and audit preparations
- Escalates quality and compliance risks to Head of Department, QA
- Supports improvement initiatives, programs and projects of the assigned Quality Process

**Requirements**:

- Advanced Degree/Degree in Science, Pharmacy, Pharmaceutical Science, Engineering with preferably 8-10 years of relevant working experience in Quality Management System in the pharmaceutical/biotechnology/medical device industry
- With some knowledge and experience in Cleanroom Qualification, Aseptic Simulation Processing (APS), Microbiological Methods Validation/Suitability will be preferred.
- Extensive knowledge in Quality Management System concepts
- Good communication skills
- Excellent oral and written communication skills



  • Singapore Tessa Therapeutics Pte Ltd Full time

    **Company Background** Tessa Therapeutics is a clinical-stage biotechnology company developing a portfolio of next-generation cell therapies for cancer. It has a pipeline of therapies in clinical development for the treatment of hematological malignancies and solid tumors. Tessa’s lead autologous therapy is in late-stage clinical development for...

  • Associate Director

    2 days ago


    Singapore GT Group Full time

    Are you an experienced Financial Consultant who is looking for greater career advancements, or perhaps manage a team of your own? Rise to the challenge and take your career to greater heights with us! **Requirements**: - Self-driven and motivated - Motivated to groom new potential team members - No MCG or disciplinary issues - YTD persistency of at least...


  • Singapore NTUC Health Full time

    COMPANY DESCRIPTION **NTUC Health Co-operative Limited (NTUC Health)** is an NTUC social enterprise that provides a comprehensive and integrated suite of quality and affordable health and eldercare services to meet the growing needs of families and their dependents. Building on more than five decades of experience and expertise, NTUC Health is among the...


  • Singapore SPURWING COMMUNICATIONS PTE. LTD. Full time

    **Senior Account Director/Associate Director - Sustainability, Spurwing Communications At Spurwing, we have created an environment that helps our people be better every day. If you’re seeking a company that values curiosity, initiative and bold perspectives to shape the future of communication in the healthcare, nutrition and sustainability sectors then...


  • Singapore HYPERSCAL SOLUTIONS PTE. LTD. Full time

    **COMPANY DESCRIPTION** **NTUC Health Co-operative Limited (NTUC Health) **is an NTUC social enterprise that provides a comprehensive and integrated suite of quality and affordable health and eldercare services to meet the growing needs of families and their dependents. Building on more than five decades of experience and expertise, NTUC Health is among the...


  • Singapore Unity Denticare Full time

    **About Us**: **NTUC Health Co-operative Limited (NTUC Health)** is an NTUC social enterprise that provides a comprehensive and integrated suite of quality and affordable health and eldercare services to meet the growing needs of families and their dependents. Building on more than five decades of experience and expertise, NTUC Health is among the largest...

  • Associate Director

    18 hours ago


    Singapore Singapore Management University Full time

    COMPANY DESCRIPTION Singapore Management University is a place where high-level professionalism blends together with a healthy informality. The 'family-like' atmosphere among the SMU community fosters a culture where employees work, plan, organise and play together - building a strong collegiality and morale within the university. Our commitment to attract...


  • Singapore Ling Kwang Home For Senior Citizens Full time

    We are looking for an experience and self-driven Assistant Director of Nursing (ADON) to aide Director of Nursing in managing the day-day operations of Ling Kwang Home for Senior Citizens in accordance with the current Ministry of Health, Singapore Nursing Board and Agency for Integrated Care guidelines and regulation. ADON is to provide dynamic leadership...


  • Singapore FEHMARN CONSULTING PTE. LTD. Full time

    Our client is look for a dynamic individual to join them as Senior Associate or Associate. **Position Summary** To support our growing climate & sustainability/ESG advisory and assurance business across the region, we seek for associates to join our team. As a member of our team, you will assist the managers, directors, and partners on ESG advisory and...

  • Associate Director

    2 days ago


    Singapore Singapore Management University Full time

    COMPANY DESCRIPTION Singapore Management University is a place where high-level professionalism blends together with a healthy informality. The 'family-like' atmosphere among the SMU community fosters a culture where employees work, plan, organise and play together - building a strong collegiality and morale within the university. Our commitment to attract...


  • Singapore OLIVER - SEAPAC Full time

    **Job Title**: Associate Account Director **Location**:Singapore **A LITTLE BIT ABOUT THE ROLE**: OLIVER is a rapidly expanding creative services agency with a twist - we provide our clients with bespoke dedicated agencies that operate from within their offices. We are building a team of individuals who have the ability and confidence to learn on the job...


  • Central Singapore Emprego SG Full time

    **Location** Singapore, Central Singapore **Job Type** Permanent **Date Posted** 7 hours ago Additional Details **Job ID** 94862 **Job Views** 45 **Job Description**: **Job Description**: - Oversee the maintenance management of facilities and services for a designated cluster of buildings in a smart, safe and sustainable manner. - Manage the...


  • Singapore Information Technology Senior Management Forum Full time

    Posted Date 2/06/2025 Description **Job Description Summary**: **We are the makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and...


  • Singapore Beca Full time

    **About Beca** Beca is one of Asia Pacific’s largest independent advisory, design and engineering consultancies. After a century of operation, we have grown from a family-owned business to one of the most progressive, client-centric professional services consultancies in our region. We have more than 3,300 employees in 21 offices around the world and have...


  • Singapore TRIBAL WORLDWIDE PTE. LTD. Full time

    **Associate Account Director** Tribal Worldwide is a full-service interactive agency that focuses on across the board front-end digital solutions from web to mobile and beyond. Tribal Worldwide is committed towards creating digital solutions through original digital marketing programmes which generate compelling experience for the end-user. First founded in...

  • Associate Director

    3 days ago


    Singapore APCO WORLDWIDE ADVISORY SERVICES PTE. LIMITED Full time

    **Job Description & Requirements**: Founded in 1984, APCO Worldwide is an award-winning, independently owned global communication and business strategy firm with offices in major cities throughout North America, Europe, the Middle East and Asia. APCO combines a global perspective with local expertise to help clients around the world manage challenges,...

  • Associate Director

    18 hours ago


    Singapore APCO WORLDWIDE ADVISORY SERVICES PTE. LIMITED Full time

    **Job Description & Requirements**: Founded in 1984, APCO Worldwide is an award-winning, independently owned global communication and business strategy firm with offices in major cities throughout North America, Europe, the Middle East and Asia. APCO combines a global perspective with local expertise to help clients around the world manage challenges,...


  • Singapore Tandem Search Full time

    **Overview**: A leading independent global professional services firm, specializing in providing turnaround management, performance improvement and corporate advisory services. With more than 5,500 professionals based globally, the firm excels in problem solving and value creation. Drawing on a strong operational heritage and hands-on-approach, their...


  • Singapore Black & White Engineering Full time

    **Mechanical Associate Director - REF:SG2021MECHAD-1011** Due to our continued growth into the Data Centre sector, we are looking to recruit a **Mechanical Associate Director, **with Data Centre experience, to lead our multi-disciplined teams on technically challenging projects. As a fast-paced, growing business; this role will be responsible for managing...


  • Singapore Drew Napier Full time

    **Dispute Resolution Associate / Senior Associate (Commercial Dispute and Construction)**: You will assist the directors with contentious commercial and construction matters. **Requirements**: - 1 to 6 years PQE with relevant working experience. Construction law experience or training is a plus.