CDD - Commercial Quality Manager CCHI (H/F)

This position is responsible for ensuring that the CCH International entity, and more specifically Nordics and Africa & Whitespace regions, maintain compliance to applicable procedure, systems and regulations as appropriate (medicines, food supplements, biocides, medical devices, cosmetics) while also supporting and enabling the business to achieve its objectives.  The Manager must work effectively with internal parties and functions, manufacturing sites, third parties, distributors, external bodies and corporate personnel.

Main key responsibilities:

-        Directly accountable for the quality oversight of Nordics, Africa & Whitespace regions

-        Quality support for the CCHI products portfolio.

-        Quality oversight of commercial, freight operations, distribution centers, distributors, copackers

Coordination of resolution of any quality, compliance and safety issues affecting products in market

Tasks and Responsibilities:

LOCAL QUALITY MANAGEMENT SYSTEM (QMS)

1.      Responsible to support the GM’s and their management teams to enable them to develop and implement the Quality Management System (QMS) to ensure fully compliant products.

2.      Provide leadership on continuous improvement projects & quality initiatives

3.      Work with local functions to develop and maintain all relevant procedures in line with the requirements of the Global QMS & associated policies, relevant codes of practice and GDP.

4.      Ensure with CCHI Quality team that the QMS is maintained in a state of inspection readiness.

5.      Change Management - Develop and maintain a robust and effective change control system to ensure business changes are effectively managed.

6.      Training – Develop and carry out training for each business relevant to the CCH global & local QMS, and in cooperation with local Regulatory any significant changes in the legislation which impact the business.

7.      Issue and complaint Management – Handle customer complaints, investigate quality issues and failures (Critical Events) and apply Corrective and Preventive Actions (CAPA) to prevent recurrence. Ensure that improvements to products and procedures can be identified and fixed.

8.      Audit/Self-Inspection Management – Ensure that processes are in place to assess the adequacy and effectiveness of the local QMS. Audit should cover all aspects of the global and local QMS to ensure compliance. Ensure a routine review programme and audits are in place for Third Party providers.

9.      Document Management – Maintain a document control system for the local QMS. Perform reviews and approve business Standard Operating Procedures (SOP) & Technical Agreements.

10.   Product Recall - as per the CCH SOP establish and communicate responsibilities. Conduct mock recall exercises to confirm adequacy of the local recall procedure.

11.   Risk Management - lead intelligent risk assessment, and evaluation, interpretation of data and trending, and promote actionable risk remediation & prevention actions

FREIGHT, DISTRIBUTION, CO-PACKING and other third parties

12.   Responsible for the quality oversight of freight-in operations, distribution and co-packing activities.

LOCAL QUALITY MANAGEMENT SYSTEM (QMS)

1.      Responsible to support the GM’s and their management teams to enable them to develop and implement the Quality Management System (QMS) to ensure fully compliant products.

2.      Provide leadership on continuous improvement projects & quality initiatives

3.      Work with local functions to develop and maintain all relevant procedures in line with the requirements of the Global QMS & associated policies, relevant codes of practice and GDP.

4.      Ensure with CCHI Quality team that the QMS is maintained in a state of inspection readiness.

5.      Change Management - Develop and maintain a robust and effective change control system to ensure business changes are effectively managed.

6.      Training – Develop and carry out training for each business relevant to the CCH global & local QMS, and in cooperation with local Regulatory any significant changes in the legislation which impact the business.

7.      Issue and complaint Management – Handle customer complaints, investigate quality issues and failures (Critical Events) and apply Corrective and Preventive Actions (CAPA) to prevent recurrence. Ensure that improvements to products and procedures can be identified and fixed.

8.      Audit/Self-Inspection Management – Ensure that processes are in place to assess the adequacy and effectiveness of the local QMS. Audit should cover all aspects of the global and local QMS to ensure compliance. Ensure a routine review programme and audits are in place for Third Party providers.

9.      Document Management – Maintain a document control system for the local QMS. Perform reviews and approve business Standard Operating Procedures (SOP) & Technical Agreements.

10.   Product Recall - as per the CCH SOP establish and communicate responsibilities. Conduct mock recall exercises to confirm adequacy of the local recall procedure.

11.   Risk Management - lead intelligent risk assessment, and evaluation, interpretation of data and trending, and promote actionable risk remediation & prevention actions

FREIGHT, DISTRIBUTION, CO-PACKING and other third parties

12.   Responsible for the quality oversight of freight-in operations, distribution and co-packing activities.

13.   Responsible for initial compliance assessment and approval of Distribution Centers, Distributors & co-packers handling products.

14.   Prepare Technical Agreements (TAs) for Distribution Centers, Distributors & Co-packers – ensure all quality expectations are included (e.g. change management, product handling, product release, responsibilities).

15.   Responsible for continuous compliance & quality follow-up of approved Distribution Centers, Distributors & Co-packers

INTERFACE WITH OTHER FUNCTIONS

16.   Work with global, manufacturing & CMO Quality teams to ensure implementation of appropriate controls to ensure consistent quality of products

17.   Develop and maintain key partnership with CCHI teams & functions (GMs, operations, regulatory, legal, marketing etc.) as well as global functions.

CO-ORDINATE INSPECTIONS/AUDITS

18.   Co-ordinate and host external inspections by External Authorities, third-parties, and CCH in cooperation with Regulatory.

19.   Co-ordinate follow ups and responses after external inspections. Ensure that any CAPA is resolved in a timely manner.

Required qualifications and work experience:

Knowledge of the following standards:

·       Directive 2001/83/CE relating to medicinal products

·       Good Distribution Practices for medicinal products

·       Public Health Code

·       European and French Good Pharmacovigilance Practices

·       ISO 22716/13485

·       Food Supplements regulations

Professional Qualifications:

·       Master Degree in Quality, Chemistry, Regulatory or Degree in Pharmacy

·       At least 5 years’ experience working in a quality function in Healthcare, Pharmaceutical, Cosmetics or Medical Device related industry

·       Auditing skills, appropriate qualifications in auditing an advantage.

·       Experience in developing and maintaining a robust QMS

·       Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks.

Good understanding of regulatory, GMP and GDP requirements relevant to a regulated product

Required core competencies:

·       Agility to navigate across complexity- technical and matrix organization

·       Results oriented, entrepreneurial & self-motivating

·       Bias for action, capability to define, evaluate & take risks

·       Influencing skills in areas with no direct reporting authority. Capability building strong working relationships and motivating teams to deliver outstanding results

·       Strong leadership, motivational, interpersonal skills

·       Commercial understanding of operational business issues

·       Ability to transform solid thinking into action (a thinker & an achiever)

·       Appetite for exploring new and previously uncharted territories

·       Openness to change and ability to think out of the box

·       Strong communication skills both written and oral (in English)

·       Excellent Presentation skills

·       Fluent in French and English