Senior QA Operations Expert

at  Novartis

SUMMARY

As Senior QA Compliance Expert you will support, facilitate and drive on-site regulatory CMC related launch and post-approval activities (post-approval changes, transfers, remediation, divestment, pruning and due diligence) of the Campus products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements and champion experience sharing within the site and develop in collaboration with multidisciplinary teams (operations, MS&T, QC/AS&T, QA Compliance) lean concepts for manufacturing equipment expansions and transfer activities to facilitate fast and cost-efficient rollout of product portfolio and actively participates in cross-site regulatory CMC network to drive consistency for cross-site products and processes to simplify way of working End-to-end.

MAJOR ACCOUNTABILITIES:

Your responsibilities include, but are not limited to:

• Leading the group of site Reg CMC facilitators to establish a knowledgeable group in the field of regulatory compliance; responsible for big/medium/small country/ product portfolio regulatory affairs excellence and compliance activities for the assigned portfolio, driving alignment & strategy and enhance quality and consistency of CMC/RA regulatory compliance activities in Region through implementation of new processes, policies, metrics and appropriate training
• Regulatory Compliance: Support and address issues related to regulatory compliance checks. Maintain an oversight of any compliance remediation activities at the site, ensuring appropriate handling and prompt completion of remediation activities; ensures creation of and reviews relevant remedial and improvement actions for Corrective Action Plans from Audits/Inspections and is also responsible for completion and implementation of relevant tasks to ensure closure; leads process excellence support as provided to CMC/ RA groups and other key stakeholders
• Coach, train and develop campus personnel on regulatory specific aspects of change management by sharing lessons learned and regulatory intelligence information with the goal of improving their skills and capabilities for handling change requests and maintaining regulatory compliance and support sites in setting standards for regulatory relevant information included in CMC modules
• Submission support: Support the CMC documentation preparation by facilitating timely provision of good quality source documentation, involving co-authoring as applicable, and accurate comments from technical experts to RA CMC while ensuring regulatory compliance, quality oversight and adherence to best practices. Ensure activities completed without delays. Address and escalate issues adequately and in time
• Regulatory transmission: Act as single point of contact and advisor for worldwide regulatory intelligence information on the site. Maintain a close collaboration with RA CMC and RA in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3)
• Health Authority Responses: Provide on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA) requests for site specific products, balancing internal and external customer focus considering Novartis global interests. Ensure overview and timely follow-up to commitments impacting the site
• Participate in the CMC facilitator network sharing lessons learned, providing expertise to facilitators from other sites and raising issues for resolution. Participates in cross-functional process improvement projects; Change control: Support the Campus in generation of effective change control strategies with focus of end-to-end view for the products
• Handling of all complex changes and related projects and drives the strategy; verify regulatory relevance of changes including performance of regulatory pre-evaluation of changes. Provide regulatory strategic guidance as member of local change control board. Consider current regulatory requirements and trends in order to ensure accuracy and completeness; manages deviations/incidents/change evaluations/dossier filling strategies together with CMC/RA groups according to timelines

MINIMUM REQUIREMENTS:

• Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Desirable: Advanced degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• 5-8 years work history in pharmaceutical industries with special focus on experience in REG CMC area
• fluent English is required
• Project Management and Regulatory Compliance
  Why Novartis?
  Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
  You’ll receive:
  You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
  In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 60.600/year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
  We are open for part-time and job-sharing models and support flexible and remote working where possible.
  Commitment to Diversity & Inclusion:
  Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.
  Adjustments for Applicants with Disabilities:
  If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to disabilities.austria@novartis.com and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
  Join our Novartis Network:
  If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/networ
  Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
  Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
  Division
  Operations
  Business Unit
  Pharmaceuticals
  Location
  Austria
  Site
  Schaftenau
  Company / Legal Entity
  AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH
  Functional Area
  Quality
  Job Type
  Full time
  Employment Type
  Regular
  Shift Work
  No

ADJUSTMENTS FOR APPLICANTS WITH DISABILITIES

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Your responsibilities include, but are not limited to:

• Leading the group of site Reg CMC facilitators to establish a knowledgeable group in the field of regulatory compliance; responsible for big/medium/small country/ product portfolio regulatory affairs excellence and compliance activities for the assigned portfolio, driving alignment & strategy and enhance quality and consistency of CMC/RA regulatory compliance activities in Region through implementation of new processes, policies, metrics and appropriate training
• Regulatory Compliance: Support and address issues related to regulatory compliance checks. Maintain an oversight of any compliance remediation activities at the site, ensuring appropriate handling and prompt completion of remediation activities; ensures creation of and reviews relevant remedial and improvement actions for Corrective Action Plans from Audits/Inspections and is also responsible for completion and implementation of relevant tasks to ensure closure; leads process excellence support as provided to CMC/ RA groups and other key stakeholders
• Coach, train and develop campus personnel on regulatory specific aspects of change management by sharing lessons learned and regulatory intelligence information with the goal of improving their skills and capabilities for handling change requests and maintaining regulatory compliance and support sites in setting standards for regulatory relevant information included in CMC modules
• Submission support: Support the CMC documentation preparation by facilitating timely provision of good quality source documentation, involving co-authoring as applicable, and accurate comments from technical experts to RA CMC while ensuring regulatory compliance, quality oversight and adherence to best practices. Ensure activities completed without delays. Address and escalate issues adequately and in time
• Regulatory transmission: Act as single point of contact and advisor for worldwide regulatory intelligence information on the site. Maintain a close collaboration with RA CMC and RA in order to keep track of new regulatory requirements, strategies and the knowledge of the global product dossiers (CTD module 3)
• Health Authority Responses: Provide on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA) requests for site specific products, balancing internal and external customer focus considering Novartis global interests. Ensure overview and timely follow-up to commitments impacting the site
• Participate in the CMC facilitator network sharing lessons learned, providing expertise to facilitators from other sites and raising issues for resolution. Participates in cross-functional process improvement projects; Change control: Support the Campus in generation of effective change control strategies with focus of end-to-end view for the products
• Handling of all complex changes and related projects and drives the strategy; verify regulatory relevance of changes including performance of regulatory pre-evaluation of changes. Provide regulatory strategic guidance as member of local change control board. Consider current regulatory requirements and trends in order to ensure accuracy and completeness; manages deviations/incidents/change evaluations/dossier filling strategies together with CMC/RA groups according to timeline