Impact Quality Lead
Apply NowCompany: UCB
Location: Atlanta, GA 30349
Description:
Make your mark for patients
We are looking for an Impact Quality Lead responsible for implementing and maintaining a balanced, proactive, global approach to pharmacovigilance (PV) compliance, to join us in our R&D and Pharmacovigilance Quality team, based in our UCB, Inc. office in Atlanta, Georgia, USA.
About the role
The Impact Quality Lead falls with the Impact Quality team within R&D and Pharmacovigilance Quality. This position is a global role responsible for ensuring pharmacovigilance (PV) activities are conducted in accordance with applicable global regulatory requirements, guidelines, polices, procedures and industry best practice. The ideal candidate for this position should possess GVP experience in the pharmaceutical industry and have work experience supporting pharmacovigilance quality assurance, along with a demonstrated track record of success in providing quality oversight to critical PV process such as case processing, aggregate reports, quality assurance systems, PV vendors, audits, Safety Data Exchange Agreements, etc. A candidate that also possesses GCP experience would be ideal.
Who you'll work with
The role will collaborate closely with UCB cross-functional teams supporting pharmacovigilance activities including the Global Pharmacovigilance organization, Affiliate Offices, Clinical Operations, Regulatory Affairs, Commercial teams, etc. Key responsibilities include overseeing the pharmacovigilance system and pharmacovigilance quality system and providing oversight to Phase IVs studies and post-marketing commitments.
What you'll do
The Impact Quality Lead GVP is responsible for providing Quality oversight to the UCB Pharmacovigilance System and the UCB Pharmacovigilance Quality Management System. Specific tasks include:
Interested? For this role we're looking for the following education, experience and skills
Required Qualifications:
Preferred Qualifications:
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.
UCB is an equal opportunity employer. All qualified applicants will receive equal consideration for employment without regard to race/ethnicity, color, 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-Reasonable_Accommodation@ucb.com 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: 90178
Recruiter: Kate Broderick
Hiring Manager: Joi Arnold
Talent Partner: Sandrine Eelbo
Job Level: MM II
Please consult HRAnswers for more information on job levels.
We are looking for an Impact Quality Lead responsible for implementing and maintaining a balanced, proactive, global approach to pharmacovigilance (PV) compliance, to join us in our R&D and Pharmacovigilance Quality team, based in our UCB, Inc. office in Atlanta, Georgia, USA.
About the role
The Impact Quality Lead falls with the Impact Quality team within R&D and Pharmacovigilance Quality. This position is a global role responsible for ensuring pharmacovigilance (PV) activities are conducted in accordance with applicable global regulatory requirements, guidelines, polices, procedures and industry best practice. The ideal candidate for this position should possess GVP experience in the pharmaceutical industry and have work experience supporting pharmacovigilance quality assurance, along with a demonstrated track record of success in providing quality oversight to critical PV process such as case processing, aggregate reports, quality assurance systems, PV vendors, audits, Safety Data Exchange Agreements, etc. A candidate that also possesses GCP experience would be ideal.
Who you'll work with
The role will collaborate closely with UCB cross-functional teams supporting pharmacovigilance activities including the Global Pharmacovigilance organization, Affiliate Offices, Clinical Operations, Regulatory Affairs, Commercial teams, etc. Key responsibilities include overseeing the pharmacovigilance system and pharmacovigilance quality system and providing oversight to Phase IVs studies and post-marketing commitments.
What you'll do
The Impact Quality Lead GVP is responsible for providing Quality oversight to the UCB Pharmacovigilance System and the UCB Pharmacovigilance Quality Management System. Specific tasks include:
- Provides expert guidance on Good Pharmacovigilance Practices (GVP) and Good Clinical Practice (GCP) global regulatory expectations (FDA, EMA, ICH), and industry best practices to ensure compliance and operational excellence.
- Provides support to Phase IV study types (i.e. Non-Interventional Studies, Compassionate Use, Surveys, Managed Access Programs, Named Patient Programs, Patient Centered Outcomes Research, Registries).
- Provide oversight to UCB patient centric initiatives (including patient support programs, market research programs, digital initiatives, IIS, PASS, medical information, collaboration studies).
- Ensures PV outputs are compliant including individual case safety reports (ICSRs), development safety update report (DSURs), Risk Management Plan (RMPs), and Risk Evaluation and Mitigation Strategies (REMS), etc.
- PV Quality Management Support - The Impact Quality Lead GVP develops and executes a comprehensive and efficient Quality Assurance strategy for the critical PV processes, aligning with UCB SOPs and regulatory requirements.
- The role monitors compliance with global regulatory requirements by ensuring the implementation of appropriate SOPs, processes, metrics, and monitoring of performance and compliance, and training at a global level.
Interested? For this role we're looking for the following education, experience and skills
Required Qualifications:
- Bachelor's degree in Life Sciences, Master's degree is a plus, with 8 - 10 years of experience in drug safety/pharmacovigilance quality assurance or compliance within the pharmaceutical or biotech industry.
- Proficiency in internal auditing, partner auditing, risk assessments, compliance monitoring, and inspection management activities preferred.
- Knowledge of GVP and GCP, and applicable regulatory framework.
Preferred Qualifications:
- Ability to proactively identify, assess, and identify solutions to mitigate potential risks to the pharmacovigilance system.
- Ability to lead medium to high complexity projects.
- Excellent verbal and written communications skills in English.
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.
UCB is an equal opportunity employer. All qualified applicants will receive equal consideration for employment without regard to race/ethnicity, color, 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-Reasonable_Accommodation@ucb.com 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: 90178
Recruiter: Kate Broderick
Hiring Manager: Joi Arnold
Talent Partner: Sandrine Eelbo
Job Level: MM II
Please consult HRAnswers for more information on job levels.