Associate Director/ Senior Manager, Quality

3 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

  • Associate Director

    1 week ago

    Singapore SAA Architects Pte Ltd Full time

    Join to apply for the Associate Director role at SAA Architects Pte Ltd 5 days ago Be among the first 25 applicants Join to apply for the Associate Director role at SAA Architects Pte Ltd A career at SAA gives you the opportunity to be part of a team that makes a real difference to people’s lives; creating places and spaces that form meaningful experiences...

  • Associate Director

    2 weeks ago

    Singapore Singapore Management University Full time

    Associate Director / Senior Associate Director, Office of Advancement Overview Associate Director / Senior Associate Director, Office of Advancement Responsibilities Plan, develop and implement active and effective strategies to meet fundraising goals for the university. Work to develop gift opportunities and create proposals, which seek to match the...

  • Associate Director

    1 week ago

    Singapore National University of Singapore Full time

    Associate Director / Senior Associate Director Position: Associate Director / Senior Associate Director at National University of Singapore (NUS IT). Overview NUS Information Technology is the cornerstone to providing reliable, high-performance and secure IT solutions and effective IT governance for the campus. NUS IT aims to transform NUS into a borderless...

  • Associate Director-Senior Economist

    1 week ago

    Singapore Moody's Corporation Full time

    Join to apply for the Associate Director-Senior Economist role at Moody's Corporation 1 day ago Be among the first 25 applicants Join to apply for the Associate Director-Senior Economist role at Moody's Corporation At Moody's, we unite the brightest minds to turn today’s risks into tomorrow’s opportunities. We do this by striving to create an inclusive...

  • Senior Associate, Quality Management

    3 days ago

    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...

  • Associate Director

    2 weeks ago

    Singapore HADVISORS KLARECO PTE. LTD. Full time

    As an Associate Director in Klareco, you will be part of the senior team. You will play an important role in the management and development of the business in addition to providing senior level consultancy. In client work, you will play a leading role in large and complex accounts and you will be active in crisis readiness and response advisory. You will be...

  • Senior Manager/Associate Director

    1 week ago

    Singapore National University of Singapore Full time

    Senior Manager/Associate Director (Procurement System)Join to apply for the Senior Manager/Associate Director (Procurement System)role at National University of Singapore Senior Manager/Associate Director (Procurement System)Join to apply for the Senior Manager/Associate Director (Procurement System)role at National University of Singapore Get AI-powered...

  • Associate Director

    2 weeks ago

    Singapore HAdvisors Klareco Full time

    Associate Director (Corporate and Professional)As an Associate Director in Klareco, you will be part of the senior team. You will play an important role in the management and development of the business in addition to providing senior level consultancy. In client work, you will play a leading role in large and complex accounts and you will be active in...

  • Associate / Senior Associate / Director

    2 weeks ago

    Singapore Lawsociety Full time

    Forte Law is a dynamic firm with ongoing cutting-edge corporate projects and litigation cases. Corporate: We are seeking to hire 2 competent candidates immediately. Ideally 1 Director or Senior Associate, and 1 Associate. Experience in M&A/Capital Markets/Funds work preferred. We'd be happy to guide & train a junior associate if he/she might be interested in...

  • Associate / Senior Associate / Associate Director (Litigation & Dispute Resolution)

    2 weeks ago

    Singapore Lawsociety Full time

    Aldgate Chambers LLC Aldgate Chambers LLC is a boutique law firm in Singapore, specializing in dispute resolution. We are seeking a talented and driven Associate / Senior Associate / Associate Director to join our dynamic team. Applicants, if employed, will work closely with the senior partner in a supportive working environment and have the opportunity to...