Job Description:

As their primary role, the Biogen Biosimilars Unit (BBU) Quality Representative will provide strategic leadership for all aspects of Quality management including GCP and GVP quality/compliance oversight, representation and support for clinical development, regulatory and safety teams in the BBU. The successful candidate will partner with BBU clinical development teams to oversee GxP compliant planning and execution of the respective biosimilar development programs; provide quality updates to the BBU head, identify and escalate quality/compliance risks; provide quality oversight of safety and clinical processes (e.g. TMF); lead quality issue investigation and remediation efforts, approve CAPAs and effectiveness checks where necessary; participate in vendor governance meetings within the BBU; support vendor qualifications and; support audit and inspection readiness, planning, management and response generation.

 The BBU Quality Representative partners with Quality and Compliance groups within and outside BBU  to enable transparency & escalation of quality and compliance issues to the appropriate quality team. The Quality Representative provides risk-based rationale to enable decision-making and supports the development and execution of effective and comprehensive action plans to address quality and compliance risks within the BBU. The Quality Representative consults on CAPA prioritization, development and execution with regards to major and critical audit or inspection findings. In coordination with R&D Quality and Compliance Quality Risk Management team, this role evaluates relevant metrics, proactively assesses potential risks and recommends mitigating / remediating actions to quality leads within BBU Functions.

Key Responsibilities Include:

• Assures internal and external (clinical sites/vendors/CROs) adherence to GCP/GVP and applicable regulations

• Participates in vendor selection and qualification processes

• Partners with R&D Audit to support, prepare for and facilitate internal, trial site, vendor and TMF audits

• Manages trial site and sponsor regulatory inspection readiness preparations, inspection conduct and provides Quality input and leadership to the development of responses to inspection findings

• Provide GCP consultative support to clinical study and program teams

• Identifies process and functional quality risks and forms mitigation strategies; leads investigation strategy for identified quality issues; reviews and approves SOP deviations, CAPAs and effectiveness checks; and determines requirements for escalation to senior leadership and functionally based quality leads

• Drives execution of BBU quality related initiatives by utilizing a matrixed quality organization

• Participates in steering committees to provide governance and oversight of quality and compliance issues across R&D (including quality oversight of vendors); acts as quality liaison with vendor quality ambassadors as needed.

Education:

Bachelor’s degree required, Masters or PhD in biology / chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred

Experience and Essential Skills

• At least 10 years pharmaceutical or biotechnology drug development experience; biosimilar experience preferred

• 5-6 years in a quality or compliance related discipline or equivalent quality management activities

• 5-6 years GxP QA or Compliance experience, with a strong working knowledge of GCP and/GVP experience in multiple disciplines

• Demonstrated experience with building a quality management system or equivalent cross-functional project/system

• Must be flexible and comfortable with a risk-based approach to quality and ownership of quality across functional lines

• Working knowledge of international GxP regulations, including USA (FDA), EU (EMA and MHRA) Japan (PMDA), and ICH Guidelines

• Strong strategic, critical thinking skills with ability to influence senior leadership across Worldwide Medical, Legal, Affiliates, Corporate Compliance and IT

• Excellent communication skills, verbal, written and presenting skills in English, as well as diplomacy, cross cultural and team skills.

• Working knowledge of Microsoft Office, SharePoint, Outlook and audit management systems

• Ability to thrive in a fast-paced environment, manage multiple projects simultaneously, prioritize workload and deliver assigned tasks with minimal supervision.