Country Quality Head Turkey

Job title: Country Quality Head Turkey

Hiring Manager: CHC Zone Quality Head AMET

Job location: İstanbul

Job Type: Permanant

At Opella Healthcare, we are united by one shared Mission – we work passionately every day, to put Health in Your Hands. We are committed to making healthcare as simple as it should be, thus helping people help themselves. This Mission is the core of our philosophy, driving all that we do to focus on people—our consumers, customers, healthcare professionals, employees, and the Opella Brands that support them.

As a top-three global player in Consumer Healthcare, we are raising the bar with a bold ambition to grow, perform, and outpace the market. We aim to build a more agile and responsive organization capable of delivering our Vision and Mission. To achieve this, we need exceptional talent to shape Opella’s future and help us succeed. Together, we embrace our Challenger spirit, driven by our commitment to be Outcome-obsessed, Courageous, Radically Simple, and All In Together.

About the job:

- Lead and manage the implementation and maintenance of the CHC Affiliate Quality System (covering GxP and health-regulated activities) across the local CHC Commercial organization, to ensure that quality processes and activities in scope are executed in compliance with the CHC Global Quality standards and applicable GxP regulatory requirements.

- Secure delivery of safe, efficient, quality CHC products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities.

- Focal point of contact in front of the Competent Authorities for any CHC product quality/technical, GMP and GDP-related matter.

Key Accountabilities:

• Define, implement, manage and control the CHC Affiliate Quality system across the CHC commercial office, in compliance with CHC Global Quality Policy and standards and with local applicable regulatory requirements.

• CHC Affiliate Quality Documentation Management System :

  • Organize within the CHC Affiliate a consistent management of Quality Documents related to GxP and health-regulated activities.

  • Implement a screening process of released CHC Global Quality Documents and of local regulations to capture the requirements that must be transcribed into CHC Affiliate Quality Documents.

  • Provide guidance to CHC Affiliate Functions to develop or update local Quality Documents and related training modules in their respective domains.

• CHC Affiliate GxP regulatory inspections:

  • Manage CHC Affiliate regulatory inspections related to GxP processes owned by the CHC Affiliate Country Quality Head and provide support to and coordination to other GxP Affiliate Functions in country 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 local regulations and/or expectations of the local Regulatory Authorities, in coordination with CHC Affiliate Regulatory Affairs, support the Health Authorities in their inspections of foreign manufacturing sites.

• Act as the primary contact for GxP quality system audits performed by CHC Global Quality Audits (GQA) within the CHC Affiliate, and support CHC GQA in their audits preparation, conduct and follow-up.

• Define and implement a strategy for local audits based on risk management criteria, of key local GxP and health-regulated subcontractors directly managed by the CHC Affiliate; assure the coordination of the execution of the audits managed at CHC Affiliate level.

• Training: Ensure appropriate training to quality basics/quality matters of the CHC Affiliate personnel.

• Carry out an annual CHC Affiliate Country Quality Review, including quality oversight on activities executed by CHC Affiliate GxP and health-regulated Functions, and monitor the progress status of the defined Affiliate Quality program actions.

• Define and implement across the CHC Affiliate a process to manage deviations & CAPAs related to all GxP and health-regulated activities (including those related to audits & inspection observations) and ensure appropriate training of the affiliate personnel in scope.

• Set up across the CHC Affiliate 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.

• Monitor and periodically report CHC Affiliate Quality KPIs defined by CHC Global Quality (and any other additional relevant local quality indicators).

• Ensure that valid and signed Quality agreements (with the CHC Affiliate as Contract Giver) are in place (with internal CHC manufacturing sites, distribution centers, and/or External Manufacturing hubs, CMOs, distributors), for all GDP/GMP activities under the responsibility of Quality within the CHC Affiliate organization; ensure that quality-related clauses are in place in service agreements for all subcontractors of GxP and health-regulated activities for CHC Affiliate. Ensure that the CMOs have the required list of Quality Documents always effective and in-use . Ensure that the batch release of the finished products by the CMOs is done in accordance with the specifications, Sanofi and the Quality Agreement’s requirements Follow-up on major and critical deviations or OOS impacting Sanofi products/processes. Review and approve change controls impacting Sanofi products/processes Ensure receipt and review of CMO PQR’s.

• Ensure 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 CHC Affiliate Functions, as appropriate. Identify and investigate the risks at the CMOs’ level and follow up using a defined action plan

• Ensure that quality risks are properly managed across the CHC Affiliate

• Escalate and manage the quality events occurring within the CHC Affiliate according to defined processes and standards.

• Ensure the availability of up-to-date administrative records (e.g. CV, Job Description, Training log) for CHC Affiliate Quality positions as well as CHC Affiliate up-to-date organization charts; provide guidance to CHC Affiliate GxP and health-regulated Functions to be compliant with this requirement.

• Maintain an up-to-date local inventory of GxP computerized systems and GxP spreadsheets in use within the CHC Affiliate for GxP and health-regulated activities, and guarantee they are validated by the relevant ITS functions in charge.

• Manage CHC products quality complaints received by the CHC Affiliate and perform trend analysis.

• Lead and coordinate CHC product batch recalls and ensure prompt execution of recall operations in coordination with other Functions within the CHC Affiliate, as per CHC Global Quality recall process.

• Ensure quality oversight on management of CHC product distribution issues including temperature excursions.

• Where applicable (as per local regulatory requirements):

  • Perform local Market Batch Release/Disposition

  • Ensure quality oversight on local distributors (“Buy & sell CHC products” partners)

  • Manage notifications from and to local Health Authorities for CHC product related quality events in liaison with other CHC Affiliate Functions as appropriate

• As CHC Affiliate Quality Business Partner, foster quality culture across the CHC Affiliate, interact closely with CHC Affiliate Senior Leaders to provide appropriate quality input and agile support to local CHC business.

• Manage CHC Affiliate Quality budget.

• Ensure an appropriate process for product protection against counterfeits.

As CHC affiliate Responsible Person (RP):

• The Responsible Person is responsible for conducting batch release by enabling that CHC medicinal products for human use and active substances are manufactured and controlled in compliance with:

•  the “Regulation on the Manufacturing Sites of Medicinal Products for Human Use”

• “Guideline for Operating Permit for Batch Release Sites”,

•  the principles of Good Manufacturing and Good Distribution Practices

• and marketing authorization conditions.

• The RP is also responsible for submitting batch record to the inspection of Turkish Agency's authorities when requested and keep these batch records for at least five years.

• RP is responsible for the release of each batch of imported medicinal product for human use to our country’s market after conducting necessary Turkey tests and controls in accordance with the product marketing authorization file/specifications along with importation and with the Agency requirements.

• The RP is responsible of sales of Medical Devices in compliance with the Regulation on Medical Devices Sales, Marketing and Promotion and “Medical Device Authorization License for Sales place”.

• The RP is responsible for the registration of the medical devices into the Drug Tracking System of the Agency

• The RP is responsible for the Food Supplements registration license

Management Responsibilities

The role holder reports into CHC Global Quality organization. He/she should have a direct access to the CHC Affiliate General Manager/Country Chair.

The CHC Affiliate Quality Head/ Responsible Person should have a level of authority to ensure GMP/GDP practice is adhered across the CHC Affiliate organization.

Latitude of action

The role holder is required to work autonomously and to take decisions in line with CHC Global Quality Policy, Standards and Processes.

Role impact

lt is a key role in ensuring consistent application of Quality requirements across the CHC Affiliate.

Scope

It works directly with CHC Affiliate Scientific/Medical Affairs, Regulatory Affairs, Pharmacovigilance, Supply Chain as well as with colleagues from other Quality operational units as required

Required skills / (Key skills)

The Responsible person is required to graduate from pharmacy or medicine or to hold bachelor’s degree of at least one of the four-year chemistry departments.

Specific Working Experience:

• Practical experience over at least two years in one or more undertakings which are authorized to manufacture medicinal products. The experience shall be evidenced by the insurance premium certificates and declaration of the employer in the field of production, quality assurance or quality control activities of medicinal products. However, if Responsible Person has PhD degree in the pharmacy, medicine or chemistry departments than no practical experience over at least two years is required.  

• Practical experience in Quality System Management in Health regulated industry.

• Knowledge & experience in Medical, Clinical or in pharmacovigilance domain.

• English Fluent.

Knowledge (theoretical)/Required Skills

GxP (namely GMP, GDP) and health regulated regulations

Quality Systems/Affiliate Quality management (commercial organization)

Continuous improvement management

Quality risk analysis/ Quality risk management

Soft/Lead Required Skills

Act for change with agility

Commit to customers

Cooperate transversally

Strive for results

Decision making

Problem solving

Business Partnering

Communication skills (oral & written, English)

Internal and external networking capability

Why Choose us?

• an international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.

• access to internal recruitment and development libraries - you can create your own career path within Sanofi; your professional development will be supported purposefully.

• flexible home office policy, with a possibility to work up to 50% of time from home, where you can easily schedule your office days

• an attractive package of benefits

• Employee Assistance Program (mental health support, legal and financial consulting)

• Gender neutral paid parental leave as well as volunteer days

If the description fits your experience and has aroused your interest, please apply so we can get in contact with you!

PursueProgress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Opella, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!