340826BR
May 10, 2022
United Kingdom

Job Description

118+! Projects in clinical development delivering quality medicines. Do you want to contribute to advancing a highly productive and valuable pipeline?

Reporting to the Global Head of Global Development Quality (GDQ) and interacting across R&D, the Director Compliance Advisor GCP/PV will serve as the interface between the Global Head QA Compliance and team and the GDQ/NIBR (Novartis Institutes for BioMedical Research) organization. The incumbent is responsible for establishing, reviewing and coordinating the Global GCP/PV compliance strategy and ensuring visibility to and alignment with the overall Novartis Compliance Strategy.

This position is supported by the Head Global Development Quality (GDQ), Head of Compliance QA and Head GPE. The incumbent will coordinate and work alongside associates accountable for implementing the GCP/PV compliance strategy worldwide, providing governance and compliance leadership and oversight through risk-based system assessments relating to Health Authority Inspections, audits, compliance upgrade projects and ensures remediation activities are undertaken and implemented at all affected sites and function, and verifies effectiveness.

Your responsibilities:
Your responsibilities include, but are not limited to:

• Work closely with the Global Head QA Compliance and the Head, Global Development Quality to design, develop and globally implement risk based, GCP/PV compliance programs, tools and related policies and oversight controls.
• Represent Novartis QA in enhanced interactions with the majority of major health authorities including the FDA and EMA, to promote corporate-wide GCP/PV compliance. This includes the exchange of knowledge within Novartis in preparation for health authority/compliance inspections to prevent a disconnect relating to the correct interpretation of GCP/PV regulations, agency expectations and regulatory requirements across the Novartis network.
• Set direction for the development of strategies and provide guidance and leadership to ensure that key compliance issues and GCP/PV audit area of focus are addressed internally within Novartis by working collaboratively across all functional and geographic boundaries.
• Utilize the Novartis Compliance Alert process across all units at Novartis, to ensure significant compliance issues and events are communicated to all relevant units and are adequately addressed.
• Review GCP/PV regulations and guidance circulated for comments by major health authorities and assist in aligning functional groups to come together in developing comments focused on providing a single Novartis position especially for hot topic/ high-risk issues.
• Develop and propose recommendations based on findings from external and internal inspections and audits worldwide to ensure that adequate processes are in place to maintain current knowledge of and adherence to GCP/PV regulation and focus GCP/PV Compliance more towards preventive actions and predictive compliance by assessing evolving changes in the GCP/PV regulations that may impact future compliance.
• Provide leadership and oversight for major health authority inspections; review and add global input to inspection responses and corrective action plans to ensure consistency and appropriateness of commitments in collaboration with Functional QA units as assigned. Determine cross-functional impact and co-ordinates cross-functional corrective action plans.
• Support to develop the strategy and direction and review final company (i.e. site, business unit, functional unit and division) official responses to major Health Authorities which completely address actions being taken to correct inspectional observations. Provide expert advice to ensure consistency with company-wide responses to assure there is no disconnect regarding the approach to committed corrective actions and quality commitments among sites, business units and Divisions.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Bachelors degree in a physical science, life science, nursing, pharmacy or equivalent experience required. Advance degree preferred.
• Minimum 15 years pharmaceutical or health care related industry experience in Quality Assurance / Regulatory Affairs required, both in HA and Industry.
• Minimum 5 years GCP/PV experience with 2 years of additional experience leading/supporting GCP/PV audits/inspections
• In depth knowledge and comprehension of global GCP/PV regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
• Proven FDA or EMA experience in a quality audit, compliance role, or a former investigator to lead assessments in accordance with FDA or EU QS standards.

Desirable requirements:
• Project Management abilities
• knowledge of safety database

You’ll receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

Why consider Novartis?
766 million. That’s how many lives our products touched in 2021. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

For the Ninth consecutive year, Novartis been certified a ‘Top Employer’ in the UK (2014-2022)!

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network


We are Novartis. Join us and help reimagine medicine.

#LI-NOV = Novartis
Global Drug Development
GDO GDD
United Kingdom
London-West
Quality
Full Time
Regular
No
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340826BR

Director Compliance Advisor GCP/PV

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