Sr. Project Leader - Design Assurance

Abbott Laboratories Pte Ltd; Singapore; On-site; SGD 120,000 - 170,000; Full time

Job summary

Abbott Laboratories Pte Ltd in Singapore seeks a Sr. Project Leader, Design Assurance to ensure safety, efficacy, regulatory compliance and customer satisfaction while balancing speed to market and cost.

You will define deliverables with R&D, Technical Centers and Plant Operations, assess quality attributes, and lead risk assessments across global regulations for Abbott Nutrition products.

Qualifications

• Proficient technical writing and concise communication.
• Knowledge of regulatory standards for infant formula and nutrition.
• Ability to analyze technical data across regions.

Responsibilities

• Prepare quality documents and ensure design review is conducted.
• Lead quality performance monitoring and corrective actions.
• Lead risk assessments and mitigations in product development.
• Collaborate across R&D, Technical Centers and Plant Operations.

Skills

Technical writing

Communication

Regulatory knowledge

Data analysis

Independent work

Education

B.S. in Science-related field

Master’s degree a plus

Job description

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands, including Similac®, PediaSure®, Pedialyte®, Ensure® and Glucerna®, to help get the nutrients they need to live their healthiest life.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.


• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.


• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

As the Sr. Project Leader, Design Assurance, the Design Assurance Sr. Project Leader will assure product designs provide necessary safety, efficacy, regulatory compliance and customer satisfaction while balancing the need for speed to market as well as cost effectiveness.

The successful candidate works with their functional group peers and managers to define Design Assurance related deliverables to ensure successful scale up to commercial scale manufacturing (successful FLTS process). Together with R&D, Technical Centers and Plant Operations, the incumbent assesses critical quality attributes and ensures the manufacturability of new formulations and products.

What You’ll Do

• Prepares Quality documents and assures appropriate design review is conducted.


• Monitors product, process, package quality performance and identifies quality-related issues and trends. Works with and provides direction to functional peers and operations to develop and implement corrective actions.


• Works on problems of complex scope where analysis of situation or data requires review of defined factors.


• Exhibits high level of technical competence in data analysis and product-related calculations.


• Collaborates and provides leadership across the technical portion of the organization.


• Identify/gain agreement on design criteria, negotiate compromises, balance quality with other criteria across all functional areas. Leads risk assessments required as part of product development, identifies mitigations and drives the implementation of mitigating actions.


• Displays working knowledge of relationships between regulations, labeling, process and product. Encounters differing but recurring problems and/or duties, supports root cause analysis and problem resolution.


• Displays working knowledge of global regulations and policies related to Abbott’s nutritional products and assures products meet regulations.


• Assures that the design and testing for all Abbott Nutrition products are fully compliant with applicable regulations and Abbott policies.


• Lead/support the training of Project Leaders and Associate Project Leaders within the team, and onboarding of new team members.

Requirements

• B.S. in a Science-related field (Food Science, Chemistry, Microbiology or other technical science area); Master’s degree a plus.


• Proficient technical writing skills; able to effectively and concisely communicate issues.


• Ability to effectively organize and communicate technical information.


• Knowledge of applicable regulatory standards and requirements for infant formula and nutritional products.


• Knowledge of quality management systems and regulatory requirements.


• Ability to work and interact with many cultures across time zones and be capable of interpreting and analyzing technical data from different regions for decision making.


• Ability to work independently and/or function with minimal supervision.


• Must be able to maintain a high degree of accuracy and analytical thinking.


• Minimum 5 years of working experience in the food/nutritional industry and experience in the scale-up and commercialization of product innovations.

Location

This position is based in Singapore.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

Work shift: Standard

Medical Surveillance: Yes