Sr Manager GCP Quality Assurance Governance Research Development
Sr Manager GCP Quality Assurance Governance Research Development
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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&Ds 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 Youll 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 closeout 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 riskbased rationale to enable decisionmaking; 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 endtoend 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 closeout 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
- Bachelors 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 riskbased 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 $114000 $184000. 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 Biogens LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical dental life long and shortterm disability insurances vacation endofyear shutdown and 401K participation and matching contributions.
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a midsized biotechnology company we provide the stability and resources of a wellestablished 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 lifechanging 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 our DE&I efforts.
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 EVerify Employer in the United States.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Remote
Company Industry
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
