Biotech and Agricultural Engineering Management & Business Others Medical and Healthcare Other Science and Tech Others
3 - 5 Years
May 14, 2019
When youre part of Thermo Fisher Scientific, youll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Location/Division Specific Information
The Groningen site is a multi-product and multi-client biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (phase 1, 2 and 3) and commercial production. The facility produces recombinant proteins and monoclonal antibodies. The site must comply with cGMP rules and regulations as set by national authorities and with internationally harmonized guidelines. Compliance with these rules, regulations and guidelines is essential to ensure patient safety by the production of safe, efficacious and quality drug products and for the regulatory approval of the clients products and the license to operate for the site. The incumbent is a member of the Site Management Team and contributes to the strategic direction and success of the site. Main contacts are with clients, external advisers, regulatory authorities and internal organization.
What will you do?
Ensure, in line with companys policy, the independent operation of the QA department with respect to decision making under the applicable laws and regulations of the EMA, The Netherlands and any applicable authority.
Maintain the companys cGMP compliance, and an impeccable track record in this respect.
Bring the companys projected image with respect to QA matters up to standards, such that authorities as well as clients are satisfied.
Attribute to cost-effectiveness and profitability of the site by ensuring the first time correct decisions on QA related matters in projects, particularly ensuring proper agreement between company and client on requirements and specifications for the final bulk product.
Maintain and manage the resources within the QA group.
Appointment of new staff in the department concerned.
Implement the general objectives related to EH&S and site management into the objectives of the department
Ensure the company conforms to EH&S requirements of Thermo Fisher, in as far as quality issues are concerned.
Discuss and initiates career development and training of QA staff.
Establishes responsibilities, accountabilities, authorities and competency profiles of QA-staff and personnel.
Plans project-related activities of QA-group by matching of project-demand and resources available in consultation with Project Manager.
Plans general (quality systems or non-project-related) activities of QA-group.
Sets objectives (in consultation with Project Management and Site Management) and does yearly appraisals of the QA group.
Reports regularly to Site Manager on all relevant matters.
Installs, inspects and continuously improves structures and systems to ensure cGMP compliance.
Defines and executes and/or organizes resources for activities to be performed to ensure cGMP compliance.
Advises on QA matters of importance for the businesss strategy choices.
Manages the annual QA-budget.
Ensures a compliant Quality System for the site
Keeps abreast of QA and regulatory requirements.
Represents the QA-group in the Site-Management Team.
Represents or presents the company at (international) symposia and alike.
Represents the company in discussions with clients of authorities on cGMP matters.
Ensures proper product licenses for the site from health authorities.
Identifies external advisors, when and where necessary.
Takes part in handling QA issues in project teams.
Ensures disposition (approval/rejection) decisions by the Quality Affairs department of release of final bulk products manufactured under cGMP standards.
To advise on, agree to, final development and training plan of each individual professional in the QA group.
To negotiate and agree to the yearly personnel budget for the QA group.
To approve instructions and procedures or approve the appropriate delegation authority for such approvals.
To release or prohibit the use raw materials, intermediates and final bulk product.
To access all necessary documentation (systems) and information sources within the company related to the quality of products manufactured in the Operations group.
To shut down operations when the companys credibility and good name with respect to quality and safety of products for human use are at stake.
To (re)locate personnel of QA group to (and from) project groups.
To ensure a proper briefing from the client concerning product specifications and all relevant information related to this, before the commencement of the actual execution of the project.
Execution of Thermo Fishers policies within department.
Works on complex issues where analysis of situations or data requires an in-depth knowledge of the CMO business, the client we serve and the markets their products are sold
Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
Participates in corporate development of standards, Guidelines and Global procedures ensuring that site specific needs are reflected
Has a clear understanding of Biologics manufacturing, testing and the complexities of the products manufactured and their impact on the patient
Ensures budgets and schedules meet corporate requirements.
Creates formal and informal networks involving coordination among groups. Regularly interacts with executives and/or major customers.
How will you get here?
Academic, with managerial capacities.
Minimum 15 years experience working in biological or pharmaceutical industry
Minimum 10 years experience managing/leading a Quality/Manufacturing team/unit
Knowledge, Skills, Abilities, competences.
Preferable certification as qualified person.
Thorough understanding of pharmaceutical industry and the products manufactured at Thermo Fisher and their intended use in the market / clinic.
Knowledgeable in the manufacturing science of recombinant proteins and monoclonal antibodies
Knowledgeable in Lean concept
Communication and presentation
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
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.