CHC Scientific Affairs - Director, US Quality Head
SANOFI CHC PURPOSE AND ASPIRATION
At Sanofi CHC, we have one shared purpose - we work passionately, every day, to ‘serve healthier, fuller lives. Our marketing philosophy is driven by this purpose and everything we do is centered around people – our consumers, our customers, healthcare professionals, and our employees – across the world.
We are building brands that serve 1bn consumers worldwide, so that they can live healthier, fuller lives. In order to do this better than anybody else, we aspire to become the most consumer-centric Consumer Healthcare company. We want to be market shapers and achieve category leadership in the categories that we play in - delivered through strong global-local partnership. We are a people first business, placing consumers at the heart of everything we do through uncovering and activating deep consumer and shopper insights, for example.
As one of the top global CHC players, we want to raise the bar in terms of our strategic and operational capabilities to enable sustainable, above-market growth. In order to achieve this, we need strong talents that will help us shape the future of CHC while sharing our core values of courage, teamwork, respect, and integrity.
We have announced an exciting journey to create a fully standalone CHC business (separating the Business Unit from our Pharma company heritage, processes etc.), as we target to create the best FAST MOVING CONSUMER HEALTH company, which will require us to retain, attract and grow the best leaders in our industry.
Job Purpose and Mission
The US CHC Quality Head is responsible to:
- Lead and manage the implementation and maintenance of the CHC US Country Quality System (covering GxP and health-regulated activities) across the US CHC Commercial organization (Bridgewater, NJ), to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable US regulatory and GxP regulatory requirements. Partner closely/hand-in-hand with the CHC Manufacturing & Supply Team at the Chattanooga manufacturing and development site.
- Lead in the secure delivery of safe, efficient, quality CHC products, information, and services to ensure patients/customers safety and act as Quality Business partner to support business priorities.
- Focal point of contact in front of Regulators for any CHC product quality/technical, GMP related matter.
Potential Specific Domains
- GxP and health-regulated activities related to the development, manufacturing, distribution, and commercialization of CHC drug and non-drug products contained in the US CHC portfolio.
- Collaboration and support to other CHC country GxP and health regulated Functions (Regulatory Affairs, Medical, Pharmacovigilance, Clinical, Supply Chain, etc.) and partnership with Business Functions across CHC.
Key Contributions and Activities
- Lead, define, implement, manage, and control the CHC US Quality system across the CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements.
- CHC US Quality Documentation Management System:
- Lead in organizing within US CHC a consistent management of Quality Documents related to GxP and health-regulated activities.
- Lead the implementation of a screening process of released SANOFI/CHC Global Quality Documents and of local regulations to capture the requirements that must be transcribed into US CHC Quality Documents.
- Lead in providing guidance to CHC Country Functions to develop or update local Quality Documents and related training modules in their respective domains.
- CHC US GxP regulatory inspections:
- Lead US CHC regulatory inspections in Bridgewater, NJ (ex. FDA and DEA) related to GxP processes owned by the US CHC Country Quality and provide support to and coordination to other GxP Affiliate Functions in regulatory inspections for processes in their respective areas of responsibilities, ensuring contribution of concerned functions at Global level (as needed).
- Where applicable and required by US regulations and/or expectations of the Regulatory Authorities, in coordination with CHC US Regulatory Affairs, lead the support of Health Authorities in their inspections of foreign manufacturing sites if/as warranted.
- Lead as the primary contact for GxP quality system audits performed by Global Quality Audits (GQA) within US CHC and support GQA in their audits preparation, conduct, and follow-up.
- Lead in defining and implement a strategy for local audits based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by US CHC; assure the coordination of the execution of the audits managed at US CHC level.
- Training: Lead in ensuring appropriate training to quality basics/quality matters of the US CHC personnel.
- Lead the annual US CHC Affiliate Country Quality Review, including quality oversight on activities executed by US CHC GxP and health-regulated Functions, and monitor the progress status of the defined US Quality program actions.
- Lead in defining and implementing across the US CHC a process to manage deviations and CAPAs related to all GxP and health-regulated activities (including those related to audits and inspection observations) and ensure appropriate training of the affiliate personnel in scope.
- Lead the set up across the US CHC a process to manage the changes that may impact GxP or health-regulated process or operations by leading multidisciplinary exchanges, implementing risk assessment and action plans when necessary.
- Lead, monitor and periodically report US CHC Quality KPIs defined by CHC Global Quality (and any other additional relevant local quality indicators).
- Lead to ensure that valid and signed Quality agreements (with the CHC US Affiliate as Contract Giver) are in place (with internal CHC manufacturing sites, distribution centers, and/or External Manufacturing hubs, CMOs, distributors), for all GxP activities under the responsibility of Quality within the US CHC organization; ensure that quality-related clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities for US CHC.
- Lead in ensuring an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved on selection process, qualification and performance of audits) or through coordination with the concerned US CHC functions, as appropriate.
- Lead in ensuring that quality risks are properly managed across US CHC.
- Lead in escalating and managing the quality events occurring within US CHC according to defined processes and standards.
- Lead to ensure the availability of up-to-date administrative records (e.g. CV, Job Description, Training log) for US CHC Quality positions as well as US CHC up-to-date organization charts; provide guidance to US CHC GxP and health-regulated functions to be compliant with this requirement.
- Lead in maintaining an up-to-date local inventory of GxP computerized systems, applications, and GxP spreadsheets in use within the US CHC for GxP and health-regulated activities, and guarantee they are validated by the relevant ITS functions in charge.
- Lead and manage CHC products quality complaints (via external contractor) received by US CHC and perform trend analysis.
- Lead and coordinate CHC product batch recalls and ensure prompt execution of recall operations in coordination with other functions within US CHC, as per CHC Global Quality recall process.
- Lead where applicable (as per US regulatory requirements):
- Ensure quality oversight on local distributors (“Buy and sell CHC products” partners)
- Manage notifications from and to local Health Authorities for CHC product related quality events (including Field Alerts Reports) in liaison with other US CHC Functions as appropriate
- For NDA products part of US CHC portfolio: review and submit to local Health Authorities updated regulatory documentation and Annual Report (process and packaging changes, stability data, etc.)
- As US CHC Quality Business Partner, foster quality culture across US CHC, interact closely with US CHC Senior Leaders to provide appropriate quality input and agile support to US CHC business.
- Lead and manage US CHC Quality and Regulatory budget.
- This position will lead/manage/supervise the US Country Quality group/team.
- Other duties as assigned.
Scope of Responsibility:
The role reports into US Scientific Affairs. The role will work in close collaboration with colleagues from Science Hub North America Region (Medical, PV, Regulatory Affairs).
The role holder has access to the US CHC General Manager.
The role has the authority to ensure GxP practice is adhered across the US CHC organization.
Latitude of action
The role is required to work autonomously and to take decisions in line with CHC Global Quality Policy, Standards and Processes.
lt is a key role in ensuring consistent application of Quality requirements across US CHC.
The role/colleague works directly with Science Hub North America Region, Supply Chain as well as with colleagues from other Quality operational units as required.
Required skills / (Key skills)
Specific Working Experience: Practical experience in Quality System Management in Health regulated industry. Knowledge and experience in Medical, Clinical or in Pharmacovigilance domain. English Fluent. Practical GxP experience.
Type: Knowledge (theoretical)
- GxP (namely GMP) and health regulated Regulatory Compliance regulations.
- Quality Systems/Affiliate Quality management (commercial organization)
Type: Knowledge (theoretical)
- Continuous improvement management
- Quality risk analysis/ Quality risk management
- Commit to customers.
- Cooperate transversally.
- Business Partnering
- Communication skills (oral and written, English)
- Act for change with agility
- Strive for results.
- Decision making
- Problem solving
- Internal and external networking capability
- Project management skills
- Leadership and assertiveness skills
- Negotiation and influential skills
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.