Affiliate Quality Manager

Leads and manages a Quality function for the assigned affiliate in the assigned division.​

Primary Responsibilities

• Maintain up to date knowledge of the relevant legal requirements and GMP/GDP regulations
• Proactively monitors and oversees external regulatory changes affecting affiliate quality and compliance.
• Documentation management – Develop and maintain local procedures, in compliance with the Global Pharmaceutical Quality System Documents
• Ensures the records management requirements of any performed tasks according to Good Documentation Practices (ALCOA principles)
• Ensures the consistent alignment between local and global procedural documents with local regulatory requirements and ensures effective implementation.
• Perform periodic self-inspections
• Manage Complaints, Recalls and Returns
• Handle Deviations and Investigations
• Training of personnel involved in GxP activities
• Change control
• Manage of local Corrective and Preventive Actions
• Manage counterfeits
• Quality Risk Management
• Dealing with internal and external inquiries about the products quality
• Release commercial product batches to the local market and Investigation Medicinal Products to the local clinical investigation centers, according to the local regulations, Marketing Authorizations and Clinical Trial Authorizations
• Ensure that GMP and GDP standards are implemented and maintained
• Ensure compliance with GDP guidelines and regulations for the products distributed locally
• Implementation and maintenance of risk management for GMP/GDP-compliance risks
• Own and perform local redressing process
• Ensure batch traceability for all batches received and distributed by the local warehouse
• Ensure appropriate supervision of the supply chain, and existence of additional controls for the cold chain
• Identifies and works in partnership with key affiliate stakeholders to maintain quality standards and to support continuous improvement in the Affiliate.
• Maintain Quality Agreements with local contracted third parties (Warehouse & Distribution, Contracted manufacturer, Contracted Laboratory)
• Perform audits of contracted third parties
• Ensure compliance during Health Authority inspection

Job Specification – Qualifications, Knowledge, and Experience

Essential 

• University degree in one of the following: pharmacy, medicine, dentistry. 

Desirable 

• At least 3 years’ experience in the areas of Quality Control and/or Quality Assurance
• Master or specialization in field of drug quality would be considered as an asset

Additional Requirements - Skills, Behaviors, and Attributes

• Excellent written and oral communication skills
• Analytical and problem solving skills
• High degree of proficiency in the local language and in English
• Sense for quality assurance and details.
• Quality Management experience desired and an understanding of Risk Management is a plus.
• Experience of Health Authority Inspections and audits is desirable.
• Understanding of Quality Principles related to ISO 9001.
• Good stakeholder management and the ability to effectively collaborate across a global organization.
• Ability to influence, act as a change agent, build consensus and manage conflict in challenging situations.
• Ability to work as part of a team.
• Strong verbal and written communication skills.
• Excellent listening and decision making skills.
• Well-organized, detail oriented professional and ability to prioritize and make decisions.
• Highly self-motivated; able to lead initiatives with authority.