QA Systems Manager - Recombinant Proteins

**Job Description**

**COMPANY INFORMATION**

As part of the Thermo Fisher Scientific team, youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

**Position summary**

Our Recombinant Proteins (REP) Business Unit in Cranbury, NJ is part of our Biosciences Division. REP unites deep scientific expertise with a collaborative culture to build a product portfolio that includes cytokines, growth factors, antibodies and ELISA kits used to support the research of our academic, government, biotech, and pharmaceutical customers.

The QA Systems Manager role is a part of the Recombinant Protein Business. This role is responsible for Quality Assurance of a GMP Animal Free product line by driving technical and operational excellence. This role will report to the Director of QA, Recombinant Protein Business

**What will you do?**

+ Apply Good Manufacturing Principles (GMP) in all areas of responsibility

+ Manage and lead all aspects of quality management systems (QMS) ISO9001:2015

+ Ensure the company meets the current and future requirements for its ISO 9001:2015 certification

+ Responsible for ensuring GMP compliance and improving quality systems by leading or participating in Practical Process Improvement (PPI) projects, and/or policy/procedure optimization initiatives

+ Coordinate measurement, analysis, and improvement of QMS through internal audits and external audits when applicable

+ Engage in daily oversight and guidance of problem requests, complaint records, corrective and preventive actions to drive on-time resolution

+ Collaborate across functions and sites, demonstrating quality and manufacturing expertise to troubleshoot problems, interpret data and determine next steps

+ Lead operational performance by identification, monitoring, and trending of quality metrics

+ Lead maintenance, completeness, and accuracy of Quality records

+ Develop and deliver trainings to drive staff development, performance management and team operational efficiency

+ Demonstrate and drive the Thermo Fisher values - Integrity, Intensity, Involvement, and Innovation (The Four Is)

**Required Education/Experience:**

Education

+ Bachelor of Science from an accredited college/university in Science, Engineering, Biochemistry, Biotechnology, Microbiology, or Biomedical Engineering.

Experience

+ Minimum 5 years of relevant work experience in a Quality Assurance position within the Life Sciences industry supporting regulated products

+ Minimum 3 years supervisory experience

+ Experience and knowledge of ISO 9001 standards and certification requirements

+ Hands-on experience in controlled GMP environments; understanding of GMP production and procedures

Knowledge Skills, Abilities

+ Experience leading conversations with customers and auditors

+ Leadership, delegation, and motivation skills to impact performance and development of individuals in the Quality Assurance team

+ Possesses strong organizational skills to manage and prioritize multiple tasks while meeting delivery dates

+ Self-starter to work efficiently and independently and to troubleshoot and tackle problems.

+ Must be a self-starter, have excellent time management and organization skills, a high degree of work quality, attention to detail, and strong interpersonal skills (written and oral)

+ Proficient in Microsoft computer applications

+ Proficient in compliance software to collect, organize and interpret data

+ Ability to think strategically and work independently to troubleshoot and solve problems efficiently

+ Demonstrated ability to confidently conduct group presentations and trainings

+ Ability to travel to external customer audits

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.

We offer competitive pay, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.