JOB PURPOSE
Responsible for Quality Assurance & Regulatory site operations for External
Manufacturing & Supply
Sites in adherence to GMP guidelines / standards.
KEY ACCOUNTABILITIES
As a QA Manager:
* Third parties Management
* Ensure Quality Agreement implementation and maintenance
* Coordinate and manage Third parties ' audits (audit realization, audit report, follow up of the CAPA)
* Manage Quality review with the CMO
* Perform as per defined due date the assigned Change controls and follow up with the action plan
* Manage CMO's non conformances, investigation and CAPA follow up.
* Manage the complaints related to the CMO, review the CMO investigation report, and follow up of CAPA.
* Provide expertise to solve and mitigate product/ processes deficiencies and participate to the mitigation plan
* Assess the Product Quality Review
* Review stability plan and report provided by the CMO
* Review, approve and follow Process validation of toll out products.
* Frequent visits to subcontractors to follow up the process and to ensure the compliance to cGMP, SANOFI requirements when applicable and with local regulations.
* Participate in Quality Risk Management for identifying, analyzing, evaluating, controlling, communicating and reviewing potential or identified risks related to Quality and GxP compliance in alignment with Global Quality documents.
* Plan and organize Quality Assurance and GMP training for self and key personnel of External Manufacturing KSA Hub
* Reporting and communication:
* Report/Assess and follow up relevant KPIs (global and local)
* Report critical, significant events/ issues to the management
* Follow the escalation process for quality events
* Prepare relevant reports (Risk ranking tool, Annual Quality review…) for the management to regularly communicate on the QA activities progress and issues faced.
* Team support:
* Implement and maintain up to date the quality system
* Lead self-inspection of the hub
* Participate and/or provide support to GQA (Global Quality Audit) audits and preparation as well as CMO GMP inspections if needed.
* Back up colleagues when necessary
* Provide QA expertise to the Hub.
As a Regulatory Site Officer:
* Marketing Authorization: Launches & Maintenance:
* Prepare and/or review & approve the CMC documents (CTDs etc.) and additional documents required for regulatory files.
* Dispatch CMC documents to Global Regulatory Affairs or to affiliates.
* Follow the submission and approval of variations.
* Prepare and follow up with the renewal plan and relevant CMC documentation.
* Prepare efficiently responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed.
* Change control Management:
* Perform change control regulatory assessments and manages assigned regulatory action items on time.
* Organize Change control meeting with relevant Sanofi's stakeholders.
* Communicate the regulatory timelines and requirements, with quality and supply chain to ensure a continuous supply of compliant product to the market.
* Coordinate the change of packaging material with all stakeholders
* Regulatory compliance exercise:
* Support activities to ensure regulatory compliance, identifying, highlighting, and resolving gaps when applicable.
* General/Projects:
* Provide regulatory expertise within the Hub.
* Use time management skills to successfully meet deliverables.
* Anticipate delays in pre-defined submissions and either sets up corrective actions plan or suggests alternative solutions.
* Participate and/or provide support to GQA audits and preparation as well as CMO GMP inspections if needed.
* Manage contacts between third parties and relevant Sanofi's stakeholders for CMC related issues/topics.
* Provide input for the development and implementation of new Regulatory systems, procedures, and/or tools.
* Ensure staying up to date on regulatory guidance and technical/scientific developments.
* Participate on project teams, bring regulatory support, and communicate status to relevant stakeholders.
* Report/Assess and follow up relevant KPIs (global and local)
* Maintain Compliance
* Abide by the requirements of the internal Code of Ethics including but not restricted to maintaining high professional standards of conduct in line with the Company procedure with a duty of care to the reputation of the Company
* Ethical Leadership
* Takes personal accountability to use personal experience and knowledge, as well as the training and tools provided by Sanofi, to maintain a good knowledge and understanding of all ethics and governance relevant to the role (Sanofi Policies and Procedures and any relevant legal requirements) and demonstrate personal leadership in applying these to all work undertaken.
* Escalates any decisions, or seek the support of colleagues or management if personal knowledge and understanding is not at the level required to carry out any part of the role
* Environmental and Safety Leadership
To care for his/her own safety and wellbeing and the safety of others, and to
co-operate with the company to ensure a safe place of work. Employees are
therefore expected to:
* Support and conform to Company safety rules and procedures to ensure a safe and healthy working environment
* Report any accident, incident or near miss, whether it be of personal injury or property damage
* Assist in the investigation of accidents with the objective of introducing measures to prevent recurrence
Thoroughly read all safety documentation issues by the Company and comply with
its requirements. Escalate any doubts or uncertainties to their supervisor and
/ or manager.
JOB - HOLDER ENTRY REQUIREMENTS:
Education:
SFDA regulation related to qualified person: Pharmacist, Chemist,
Microbiologist and any other if meeting the SFDA requirements and 3 years of
experience in a GxP or regulatory affairs environment
Fluent English in writing and verbally
Related Experience:
2+ years of Regulatory Affairs CMC experience is strongly preferred.
In-depth knowledge and understanding of CMC topics, as well as KSA, European,
and International regulations/guidelines, is strongly preferred.
Quality Assurance experience in the pharmaceutical / biotech industry.
In-depth knowledge and understanding of Quality guidance, GxP environment and
third party management is strongly preferred.
Ability to manage multiple priorities efficiently is strongly preferred.
Core Competencies:
Ability to rapidly learn and be able to execute in a relative autonomy The
role holder is required to work autonomously and to take Quality decisions in
line with local regulatory requirements and Sanofi Strategy, Global Quality
Standards and Processes Excellent scientific writing and presentation skills;
ability to produce written and oral regulatory or scientific communications
with clarity and accuracy,
Ability to communicate effectively and efficiently with other functions.
Ability to lead and organize regulatory deliverables in a matrix environment
Ability and flexibility to work with multifunctional and multicultural teams
with a strong understanding of organizational and inter-cultural
sensitivities.
Ability to resolve complex issues with proactivity
Result driven with a sense of responsibility and urgency and reporting
At Sanofi diversity and inclusion is foundational to how we operate and
embedded in our Core Values. We recognize to truly tap into the richness
diversity brings we must lead with inclusion and have a workplace where those
differences can thrive and be leveraged to empower the lives of our
colleagues, patients and customers. We respect and celebrate the diversity of
our people, their backgrounds and experiences and provide equal opportunity
for all.