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Lead Quality/GxP Auditor
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Clinical Quality Lead
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University Of Michigan Medical School, Department Of Dermatology Raleigh, United StatesMake your mark for patients · We are looking for a Clinical Quality Lead who is · cooperative, insightful and quality-minded · to join us in our · Quality Assurance · team, based in either our · Raleigh, NC or Braine, Belgium · office locations. · About the role · As part o ...
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LU - 420 IT Quality Assurance Lead
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Protection and Control Electrical Engineer
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Asset Quality Lead - Raleigh, United States - UCB S.A.
Description
Make your mark for patientsWe are looking for an Asset Quality Lead who is cooperative, insightful and quality-minded to join us in our Quality Assurance team, based in either our Raleigh, NC or Braine, Belgium office locations.
About the roleAs part of the Global Quality Assurance Organization, the Asset Quality Lead (AQL) is responsible to create value, by providing quality directions and insights that protect patients, sustain compliance, including driving inspection readiness activities aiming for real-time readiness, and preserve UCBs reputation.
The AQL will focus on driving quality and compliance in the early and clinical development phases of UCB compounds, from candidate selection to life cycle management, at a global level and in partnership with the Early Solutions and Development Solutions organizations and external stakeholders.
The AQL serves as a key partner for the overall early and clinical development strategy at a compound level, in support of Sr R&D Leadership to develop and shape the future portfolio strategy as well as to align for execution and implementation.
Who youll work withThe responsibilities and activities of theEarly Clinical Development Quality team span all development phases of the UCB product portfolio until the granting of marketing authorization and at a global level.
The key responsibilities of ourECDQ Team are to ensure that quality systems are in place and monitored to prevent and pro-actively mitigate risks that could potentially impact the safety of patients and the quality of the data in our clinical trials.
The AQL will also ensure quality strategies are developed at a Compound Level, strategic and specialty vendors are selected and operating in adherence with UCB expectations and Global Health Authority inspections are appropriately led, managed.
What youll doDevelop and maintain a strategic quality roadmap/plan to execute on specific strategic initiatives that will deliver the long-term development strategy, and to document e.g.
critical to quality parameters and measures (to be) taken applicable to all development phases for the assigned compound(s), in consideration of systems applied and vendors involved.
Seek opportunities at a compound level aimed at establishing research/study design and vendor oversight that is fit for purpose, with focus on pro-actively ensuring the quality of downstream regulatory documentation, but also at the level of the systems and solutions applied to support developmental activities.
Contribute to the risk mitigation program established for UCB clinical programs, prospectively identifying critical quality risk factors, their potential impact, and developing efficient processes or solutions to manage the risks.
Independently plan, coordinate and execute quality activities (e.g. data review, spot checks) in accordance with the risk mitigation plans to validate the systems and processes established to ensure subject safety and protection and to ensure that clinical trials are performed and data are generated in adherence with the study protocol, targeted endpoints and in compliance with regulations.Review and coordinate the output of trends from audits and risk analyses prepared by colleagues, providing senior management and peers in other departments with a summary and analyses of the comparative risks and outcomes across multiple clinical programs.
Leverage internal stakeholders and SME network to develop appropriate action plans, decisions and ensure efficient actions are taken to ensure compliance.
Conduct moderate to complex analytics and qualitative assessments to deliver insights, independently from the business or other quality functions.Interested? For this role were looking for the following education, experience, and skills:
Masters degree in relevant scientific or healthcare related field.10+ years of experience working in the (bio)pharmaceutical industry with a minimum of 5+ years in the early and/or clinical development operational and/or quality domain.
Proficient in GCP regulations, applicable technical aspects, and regional specificities.Ability to translate regulatory and quality expectations into operations based on experience and knowledge of quality principles.
Expertise in Neurology, Immunology and Advanced Therapeutic Medicinal Products preferred.
Proven track record in GCP quality auditing, inspection management and clinical quality management.
Demonstrated ability to manage quality and compliance issues respectfully, with diligence, rigor, within timeliness, and in all transparency.
Experience presenting complex projects and issues in a clear succinct manner.
Must demonstrate excellent planning, organizational, presentation and training skills.
Experience in other GxP areas (GLP, GVP, GMP, GDP) is an asset.
Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months.
Please inform your Manager or your Talent Partner before applying to any internal job opportunities.As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles.
This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US- for application to US based roles.
Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Requisition ID:
86813Recruiter:
Chris Venegas
Hiring Manager:
Lauren Elizabeth Tochacek
Talent Partner:
Sandrine Eelbo
Job Level:
MM IPlease consult HRAnswers for more information on job levels.#J-18808-Ljbffr
