Manager QA in US (MA)
For our facility in Woburn (MA) we are looking for a Manager Quality Assurance for our QA department with at least 4 years of relevant industrial working experience.
As a Manager QA you will be responsible for:
- Maintaining and supporting the operation of the Company’s quality management system
- Managing Project-related, Inventory, and Equipment Documentation, Change Control, Quality Incident and CAPA Control
- Approving Study Plans and Reports
- Executing internal audits, and follow up on audit observations from internal and customer audits
- Auditing and approving parties and suppliers
- Ensuring adherence to proper quality standards in the execution customer projects.
- Make the arrangements for all Regulatory Permits including- writing new, revising and renewing existing permits, tracking and archival, etc.;
- Coordinate all facilities activities, work direction and support systems including landlord maintenance requests and internal moves;
- Develop, implement and maintain an up-to-date inventory system for all supplies and stock;
- Develop and maintain emergency preparedness plans;
- Direct and coordinate cross functional safety initiatives. The facilities manager will have in place maintenance, inspection and testing for all of the fire safety equipment and systems, record keeping and certificates of compliance;
- Distribute all incoming mail daily and ensure all outgoing daily mail is picked up or is delivered to the Post Office;
- Assist in the planning and preparation of meetings, conferences and conference telephone calls;
- Set up travel arrangements;
- Answer telephones and handle in appropriate manner.
- Generate monthly billing invoices (works closely with Financial Controller in the Netherlands)
You will join a stimulating group of international researchers in a very collaborative environment. This QA position reports directly to the Director QA / QP in the Netherlands.
Your letter of motivation and CV should show that you have:
- A Bachelor / Master degree in life science, biotechnology or related subject;
- At least four years of experience in a (research oriented) biotechnology or biopharmaceutical industry environment as QA Officer and/or Manager QA;
- Proven background in (bio)pharmaceutical QA
- Experience with performing audits of facilities, systems or suppliers is a plus.
- Good verbal and written communication skills.
Candidate will be involved in all customer projects requiring QA support.
As a successful candidate, you should demonstrate that: You are enthusiastic and comfortable in a dynamic environment. You can work both in a team and individually. You communicate clearly at all levels; you can get your thoughts, ideas and knowledge across in a helpful way. You enjoy to train R&D personnel in quality aspects of biologics development on behalf of clients. Your planning and organization skills allow you to have an overview of the necessary work and that you are able to set and meet deadlines.
You can send your motivation letter and resume to, Mrs. Ingrid van Aarle, HR Manager. Email: firstname.lastname@example.org
Acquisition regarding this position is not appreciated.