Job Description

Viatris Healthcare México S. de R.L. de C.V

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Every day, we rise to the challenge to make a difference and here is how the Supply Chain Quality Manager & Sanitary Responsible role will make an impact:

Quality Management System

• Be a liaison with the Health Authority to manage any requirement for the warehouse operation (like product disposition).

• Supports maintenance of a Quality Management System and a Quality Culture within Affiliate in compliance with internal and Regulatory Authority expectations.

• Ensures timely implementation of all applicable Quality Policies, SOP’s and WI within the area of responsibility.

• Ensures Implementation of corresponding training for personnel in the Affiliate due to update and/or creation of Quality Policies, SOP’s and WI as applicable.

• Ensures that initial and continuous training programs are implemented.

• Monitors key quality performance indicators, evaluates and highlights any significant trends and identifies actions.

• Ensures that self-inspections are performed at appropriate regular intervals following a pre-arranged program and necessary corrective measures are put in place, tracking the implementation of the identified actions within agreed timeframes.

• Assesses new quality system/local regulatory requirements and adjusts/enhances local systems and processes when required.

• Ensures that any additional requirements imposed on certain products by national law are adhered to.

• Keeps appropriate records of any delegated duties.

Local Product Disposition

• Responsible for the local release of products under the distribution license of the Affiliate Legal Entity, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.

• Supports Quality oversight of any required Quality release activities, such as but not limited to:

• Batch record review.

• Artwork Compliance check and Safety Variation implementation.

• Ensures and documents control of product certificates and transportation / temperature records obtained from product transportation for replenishment.

• Decides on the final disposition of returned, rejected (destruction), recalled or falsified products (defines requirements under which returns can be taken back to saleable stock and supports local actions, in cooperation with logistics and distribution center) and documents process as per Viatris and Regulatory Authority requirements.

• Coordinates and promptly performs any recall operations for medicinal products.

• Initiates the required actions if counterfeit products are identified.

Change Controls

• Support Management of planned, permanent, and temporary changes of GMP’s /GDP related activities and systems in the Affiliate.

• Ensures change actions completion as per the agreed timelines.

Subcontracted Activities with GMP / GQP / GDP Impact

• Approves any subcontracted activities which may impact on GMP / GDP: Develops, Negotiates and maintains up-to-date Substances Requirements, Transportation and Logistics Service Providers (LSPs).

• Develops, negotiates and maintains up to date Quality Agreements with GMP/GDP contractors

• Establishes and maintains personal contact with relevant contract representatives including the Responsible or Qualified Person to regularly review and assess quality systems, quality performance and agree action plans to ensure continuous improvement.

• Oversees quality operations at contractors which includes but is not limited to:

• Contractor Assessment and Approval ensure all GMP/GDP contractors have been formally assessed and approved.

• Deviation Management: evaluates the impact of all significant deviations affecting safety, identity, strength, purity and quality, generated at the contractor and agrees corrective actions. If necessary, initiates the “Critical Quality Notification to Management” process.

• Quality System Support: visits the contractor to assess quality systems, review quality performance and agree action plans to ensure continuous improvement

• Issue and review Metrics: periodically assess the overall quality risk associated with the contractor. Acts on adverse trends to improve contractor quality and compliance performance.

• Facilitates the Corporations Internal Audit-Functions audit process at the contractor. Help to define action plans for improvement and follow-up and communicate action closures.

Product Quality and Compliance Issues

• Deviation Management in conjunction with the Global Quality Operations as applicable.

• Initiates the “Critical Quality Notification to Management” process if required

Customer Complaints handling

• Ensures that customer complaints about product quality are dealt with effectively.

• Management of product quality complaints from customers, assignment of class and criticality to each case and forwarding to the appropriate investigating Site.

• Tracks investigation results in a timely manner.

• Informs Quality Management of significant complaints.

• Initiates the “Critical Quality Notification to Management” process if required

The minimum qualifications for this role are:

• Pharmaceutical Degree or degree related to healthcare and sciences required as per Regulation for the position of Sanitary Responsible registered in COFEPRIS.

• Strong knowledge of the quality principles, concepts and theories including quality management systems, quality guidelines and requirements including but not limited to GMP/GDP, Control Drug Substances regulation (NOM-059, FEUM, ‘Suplemento de establecimientos dedicados a la venta y suminsitro de medicamentos y demàs insumos para la salud’, NOM-072 y NOM-073).

• Previous experience of 3 years working in the Pharma Industry as Responsible Person for controlled substances.

• Fluent English communication skills-verbal and written

• Preferred experience with electronic systems: SAP, Trackwise, minitab, etc.

• Previous experience with Compliance / Regulators is a differential

• Good communication with internal and external customers

• Self-motivated individual

• Able to work and collaborate effectively in cross-functional team

A t Viatris, we offer competitive salaries, benefitsandan inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.