Supervisor, Record Lifecycle Management


BIOGEN (DENMARK) NEW MANUFACTURINGApS

Number of openings:
1
Advertisement publish date:
13/09/2017
Application deadline:
17/10/2017
Start date of employment:
As soon as possible

Job Description

We are currently looking for a Supervisor to join Biogen’s Quality Assurance Systems & Support team based in Hillerød, Denmark.

The Quality Assurance Systems & Support department consists of two teams which are characterized by working dedicated together and with counterparts across Biogen’s subsidiaries globally; the Record Lifecycle Management (RL) team and the Quality Management System (QMS) team. Record Lifecycle Management (RL) team which currently consists of five people.

In this role you will supervise the Quality Assurance System function for cGMP Record Lifecycle Management to ensure proper control and regulatory compliance globally within BIIB. You will be responsible for developing, implementing, maintaining and improving Quality Systems


Primary Responsibilities

• Supervises department personnel and ensures conformance to processes managed by the department. This includes planning, goals setting and management of personnel in accordance with the company goals

• Plans and prioritizes resource allocation to execute the responsibilities of the QA Documentation group

• Provides input to management for resource capacity planning and budgeting

• Oversee the issuance of working copies of QA Controlled documents (e.g. Protocols, MPRs, logbooks) and the archiving of QA Controlled Documents such as batch records, investigation reports, training records and validation (summary) report

• Implement and maintain GMP related Content Management System necessary to Standardization and Full Recipe execution

*LI-DEN2

Location Hillerod, Denmark
Job Category Operations, Technology & Innovation (PO&T), Quality
Requisition Number 32440BR


Qualifications

• Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel

• Strong problem solving skills with emphasis on the identification /evaluation of compliance issues

• cGMP knowledge regarding management of documentation systems and records management

• Thorough knowledge and understanding of FDA / EMA regulations and compliance

• Experience working with documentation control and records management is preferred


Education

• Degree in Bioglogy, Biotechnology, Chemistry, or related


About Biogen

Corporate Overview

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.

One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.


Our Science

We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.

For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS. As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.

Biogen is revolutionizing biologics manufacturing, developing the industry’s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.


Our Corporate Citizenship

The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek’s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science’s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.

Similar jobs

Project Manager – Global Product Lifecycle Management (PLM) project  

Project Manager – Global Product Lifecycle Management (PLM) project Nordborg, Denmark Job...project management experience and a proven track record in leading similar projects. As such, your...

Created:
Application date: As soon as possible

  • Work area: Nordborg
  • Working hours: Full time (37 hours)
  • Job type: Regular position

Solution Manager Microsoft Axapta  

...Manager will be responsible for the Axapta platform for our Marine business and be responsible for...global company ?Deep know-how and proven record of Axapta in global manufacturing companies. ?Strong...

Created:
Application date:

  • Work area: Aalborg
  • Working hours: Full time (37 hours)
  • Job type: Regular position

With offices in Western Europe and North America, and delivery centres in Central Europe and Latin America Endava have developed a set of services and propositions that support their customers on the  

Business Development Manager Nordics in major IT Services company Our customer Endava is a...You should have a demonstrable track record of originating and closing offshore/nearshore...

Created:
Application date: As soon as possible

  • Work area: København K
  • Working hours: Full time (37 hours)
  • Job type: Regular position