Job Description

The scope of this position is to oversee the strategy and execution of Quality operations for Biogen commercial products manufactured at contract manufacturing organisations (CMOs) in China as well as Distribution of all Biogen product marketed in China.

Act as Authorized Qualified Person Or Responsible Person (RP) for finished goods release/batch certification and importation, and issue product release reviewed records in China as per Drug Administration Law of the People’s Republic of China (2019 Revision), Measures for the Supervision and Administration of Drug Production of China (2020 Issuance) and Measures for the Administration of Drug Registration of China (2020 Issuance). The Authorized Qualified Person should have the expected exposure, experience and working knowledge of regulatory authorities and should maintain effective working relationships with both the Shanghai Municipal Medical Products Administration and National Medical Products Administration (NMPA).

The RP is responsible for ensuring that each individual batch has been manufactured in compliance with laws in force in China, in accordance with the requirements of the marketing authorization (MA) and with Good Manufacturing Practice (GMP).

As Responsible Person, she / he is authorized to give directives (also towards management) in her / his area of responsibility.

As Quality Head for the site, ensure the Quality Management System (QMS) provides the foundation to ensure Biogen consistently provides products that meet customer needs, applicable regulatory requirements and includes processes for continuous improvement.

This leader is responsible for communicating quality issues to senior management, driving their resolution, influencing and negotiating with the External companies (CMOs, Partners) and leading cross functional teams such as Planning, Logistics, Sourcing, External Manufacturing, Manufacturing Sciences, Quality Control, Commercial Qualities, Regulatory Affairs, Patient Services and Safety and Risk Management. He / she reports to the Global Head of Quality Commercial Operations.

This position manages the China Site Quality team and RP release delegates to ensure continuous supply of compliant Medicinal Products to China

• Accountable on API, drug products and Finished Medicinal Product release in China
  • Responsible for product release (certification and importation) and to ensure that the production and testing of each batch of released products are in accordance with the related regulations, the registration requirements and specifications
  • Prior to the release of each batch, the Qualified Person must issue a review record for product release according to the requirements in the above bullet and archive it to the batch record.
  • Ensure that all starting materials, packaging materials, intermediate, bulk and finished products meet the registration requirements and specifications
  • Ensure that the batch records are reviewed before product release
  • Ensure that all necessary testing is carried out
  • Ensure appropriate staff, training, and organization to perform efficient commercial & Clinical product release on time
  • Influence the strategy of manufacturing Biogen products at the CMOs and to sustain without disruption of the supply chain
  • Contribute to technology transfer or improvements projects through establishment of needed release process update
  • Perform Key Process Indicator analyses including feedback from other departments (for example planning). Identify appropriate actions and ensure successful implementation
  • Lead as Biogen China representative the Health Authority inspection on site
  • Manage Stakeholder for the commercial release activities through SME assessment and decision making
• Quality System
  • Identify and drive improvements/updates of the GMP/GDP/GSP documentation related to Quality System in use in China
  • To participate in quality management activities such as establishment of the quality system, self-inspection, external quality audit, validation, adverse drug reaction reporting and product recalls
  • Identify any compliance gap in Biogen processes and collaborate with appropriate stakeholders to fix the issue
  • Support local Quality system (change control, deviations, CAPAs, …) as required
  • Ensure adherence to serialization and data integrity requirements
  • Approve specifications, sampling instructions, testing methods and other quality management procedures
  • Review and approve all quality related changes
  • Ensure all significant deviations and out-of-specification results are timely investigated and handled
  • Approve and monitor any contract analysis
  • Check the maintenance of premises and equipment for the purpose of maintaining a sound operating state
  • Ensure the necessary qualifications or validations are done appropriately, and to review and approve validation protocols and reports
  • Ensure self-inspection is done
  • Assess and approve material suppliers
  • Ensure all quality related complaints are timely and properly investigated and handled
  • Ensure the implementation of on-going stability study and make stability data available
  • Ensure that the product quality reviews are done
  • Ensure that the necessary initial and continuing training of personnel in Quality Control and Quality Assurance is carried out and adapted according to need.
• Communication & Build Strategic Work relationship
  • Identify and timely communicate to the management any supply risk or risk of batch rejection
  • Able to clearly communicate expectations to internal/external customers as well as direct reports and management
  • Able to clearly report status of ongoing activities to the manager/stakeholder and highlight any time/resources constraints and propose action/time reallocation to the manager
  • Develop and sustain internal and external networking
• Decision Making
  • Has authority over the team reporting to him/her, and can make decisions regarding all aspects
  • Decisions with patient, global or regulatory impact must be taken in collaboration with upper management
  • Has authority to technically release intermediate products and to approve the certification of Finished Goods for the China Market
  • Prepares and presents information, contributing to reject/recall decisions
  • Ability to back-up peers for area of expertise
• Developing Others
  • Manage direct report(s), coach them, delegate and empower appropriately and build core skills and new competencies
  • Leads matrix teams within a product program cross functionally or at global level. May also drive project initiatives.
  • Coach indirect report(s), coach other departments on quality regulations and tools, delegate and empower appropriately and build core skills and abilities
• Innovation/Pioneer
  • Identify possibility for improvement/standardization in the purpose of continuous improvement of the system used
  • Generate and coordinate continuous improvement projects as well as ensure team commitment to innovation
  • Drive new processes set up implementation and train the • Lead/participate strategical projects/initiatives which may have significant business impacts within the company on different aspects, process/system simplification, new partnership, business expansion etc… The scope of these strategic initiatives can be local or global and Internal or External.
  • Lead/participate strategical projects/initiatives which may have significant business impacts within the company on different aspects, process/system simplification, new partnership, business expansion etc… The scope of these strategic initiatives can be local or global and Internal or External.

Qualifications:

• Master degree in th scientific field（Pharmacy, Chemistry, Biology, Biochemistry, etc)

• A minimum of 10 years of experience in pharmaceutical or biotechnology industries (small molecules and/or biotechnology and/or aseptic filling) and at least three years of practical experience in sterile drug production and quality management with work experience in in-process control, Quality testing and quality management.

• Sound knowledge of cGMP requirements, China/EU/FDA regulations and compliance. Experience in clinical products manufacturing and/or regulatory is an asset. Knowledge of medical device regulations and manufacturing is a plus.

• Experience in people management and ability to develop effective working relationships with internal/external sites and cross-functional project teams.

• Strong communication skills

• Ability to work in an international matrix environment

• Strong Negotiation skills

• Fluent in Chinese & English

Job Level: Management

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

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.