Unit Manager QA

Job profile Unit Manager QA Outsourced activities

Job Objective

QA
The Unit Manager QA is responsible for developing, managing, and strengthening relationships with external partners that support the
organization's mission, business objectives, and access strategies, including donor agencies, procurement organizations, healthcare
partners, outsourced laboratories and inspection agencies and strategic collaborators.

IDA quality system
Support IDA's quality system as per ISO 9001, ISO 14001, ISO 13485, EU GDP quality requirements

Reports to Head Quality Affairs India

Tasks and Responsibilities

1. Stakeholder relationship management

• Build and maintain strong relationships with external stakeholders
  (Global Fund, outsourced laboratories, inspection agencies) and
  access partners.
• Ensure effective communication and alignment with partner
  organizations.
• Facilitate collaboration between internal teams and external
  stakeholders.
• Manage contracts with inspection agencies and contract laboratories.
  Conduct regular business reviews and performance meetings with
  inspection agencies and contract laboratories.
  -- Prepare and deliver reports, presentations, business updates and
  briefing materials for key international customers / access partners.
• Contribute to improve business processes and develop policy and
  standards for Quality Affairs department.

2. Quality control activities

• Ensure timely preparation of methods of analysis, analytical protocols & method verification protocols.

• Assure timely review and approvals of method verification reports for
  the method verification conducted at contract labs.

• Assure timely feedback on the analytical queries as well as on OOS
  with respect to the analysis for IDA.

3. Verification audits

• Perform verification audits of contract laboratories.

4. Complaints and deviations

• Ensure proper and timely handling of quality complaints for PPM Vector control products.

• Ensure correct and timely handling of deviations observed during inspections and release of PPM Vector control products

Competences

Professional knowledge

• Demonstrates and share the knowledge related to their position. Shown interest and remains up to date with developments within their role, as well as organisations activities.

Customer focus

• Understanding, anticipating and addressing needs of the customer and acting accordingly. Giving priority to service standards and customer satisfaction

Ownership

• Accept responsibilities to own behaviour and job related tasks. Take steps to perform work at a high level in order to achieve goals. Pro-actively addresses issues that are encountered in achieving those goals.

Cooperative

• Works cooperatively with others, inside and outside the organisation, to build and maintain mutually-beneficial partnerships, leverage information and achieve results.

Knowledge and skills

• Bachelor or Masters in science field.
• At least 10 years experience working with international organizations, healthcare partners, or pharmaceutical companies.
• Persuasive and proactive in international settings.
• Knowledge on testing and analysis.
• Good presentation skills.
• Fluent in English language.