Sr Manager, GCP Quality Assurance & Governance (Research & Development)

Job Description

About This Role

The Senior Manager, GCP Quality Assurance & Governance in R&D Quality and Compliance provides global strategic leadership for quality and oversight of quality activities in Biogen R&D’s ongoing clinical research and development processes and programs, partnering with quality and compliance groups within and outside of R&D functions to enable transparency, escalation and risk minimization of R&D quality and compliance issues.

What You’ll Do

• Support the GCP annual audit strategy by functioning as a Lead Auditor in GCP audits of vendors, internal processes and investigator sites which includes managing the scheduling, planning, conducting, approval, response and close-out of the audit. Maintains holistic oversight of quality risk. This includes identifying quality risks from a spectrum of available resources; escalating risks as appropriate to drive resolution; providing risk-based rationale to enable decision-making; managing or supporting the development and execution of effective and comprehensive corrective and preventative action (CAPA) plans to address quality and compliance risks; consulting and advising on CAPA prioritization, development and execution with regards to major and critical audit findings, inspection findings and quality issues; overseeing relevant quality metrics especially those relating to inspections; proactively assessing potential quality risks and recommends mitigating / remediating actions to quality leads within R&D functions.
• Assist in the development and maintenance of the R&D Audit infrastructure, including audit risk assessment and the Annual Audit Plan, together with oversight of end-to-end audit conduct by audit functional service providers, as needed.
• Provide expertise, interpretation and guidance related to relevant and current regulations, guidelines, and industry standards to drive compliance across R&D and prepare study teams for upcoming health authority inspections.
• Support development and implementation of the R&D Quality Management System strategy, framework, methodology, infrastructure, core quality management processes and tools.
• Attend and chair relevant quality governance forums, including risk councils, as needed.

Who You Are

You function as Lead Auditor in GCP audits of vendors, internal processes, and investigator sites, including managing the scheduling, planning, conduct, approval, response and close-out of the audit.  You also provide subject matter expertise in the development and review of procedural documents related to the audits, CAPA, and observational trend analysis.  Lastly, you support sponsor inspection readiness preparations, inspection conduct, response generation, and adherence to inspection CAPA commitments.

Qualifications

Required Skills

• Bachelor’s degree required. (Masters or PhD in Biology / Chemistry, Life Sciences, Regulatory Science, Regulatory Compliance, or Drug Development preferred.)

• 5+ years of auditing experience in GCP required. 

• 8+ years pharmaceutical or biotechnology drug development experience within Quality Compliance, including strong GCP experience, required.
• 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 (EU Clinical Trial Directive 2001/20/EC and Regulation 536/2014), Japan (PMDA) and ICH Guidelines.
• Strong strategic, critical thinking skills with ability to influence senior leadership as well as Legal, Global Medical, Corporate Compliance, and IT.
• Excellent communication skills, verbal, written and presenting in English as well as diplomacy, cross cultural and team skills.
• Working knowledge of MS Word, Excel, PowerPoint, SharePoint, Outlook, and audit management systems.
• Ability to manage multiple projects simultaneously, prioritize workload for teams and function in fast paced environment as typically demonstrated during health authority inspections.
• Ability to travel 20% of time required.

Additional Information

The base compensation range for this role is $114,000 - $184,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.

Why Biogen?

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