The Position

This Commercial Quality Manager, ROPU ASKAN supports the Commercial Quality function across the ROPU (Regional Operating Unit), ensuring the effective implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in line with external regulatory requirements (e.g., GMP, GDP, GDPMD, GSP, GIP) and internal BI quality standards. The position provides centralized quality support to Operating Units (OPUs), contributes to the regional Commercial Quality strategy/activities, oversee the regional Quality Management System (QMS), and support OPU Commercial Quality operations as needed.

The role maintains oversight of the ROPU QMS through supplier and partner management, audits, CAPA oversight, quality system implementation, knowledge sharing, and self-inspection activities. It also serves as a system owner or key user for relevant quality systems, provides backup support to OPU Commercial Quality responsible persons, represents ROPU Commercial Quality in projects and initiatives, and performs additional duties as required to support business and compliance objectives.

Duties & Responsibilities:

• Oversee ROPU ASKAN QMS. Prepare and ensure readiness of Corporate audit.
• As Local MSO, SME, administrator and key user for Quality System Management and/or supporting:
  - Creation and maintenance of relevant quality system for regional/local SOPs/Working Instructions (e.g. write, review, approve, periodic review etc);
  - Ensuring that applicable Corporate Procedures are transferred into ROPU or local SOPs/Working Instructions
  - Ensuring that training on relevant Quality SOPs/Working Instructions are properly performed and documented before implementation.
  - Ensure system records are tracked, updated and closed as per established requirements/timelines.
  - Ensure system KPIs are tracked, reported and met as per established requirements/timelines.
  - Analyze any significant changes in the GMP/GDP/GDPMD/GSP/GIP environment and identify need for SOP/Working Instructions writing and/or communication to Corporate Quality (Operations Regulatory Intelligence "ORI").
• Present process evaluations and implement agreed changes for continuous improvements to the ROPU Quality Systems and Quality Manual.
• Represent ROPU ASKAN Commercial Quality and act as an interface to Global Corporate/Global Quality Organization; give feedback to Corporate/Global level quality initiatives and take actions to ROPU/OPU levels.
• Adhere to the escalation process to Head of Commercial Quality ROPU ASKAN for quality related topics and concerns (e.g. potential recall, quality defect related market returns, authority inspections, etc.)
• Serve as backup-up support for OPU Commercial Quality responsible persons on OPU commercial quality operation/activities (as needed).
• Provide support to management/execution of OPU Commercial Quality operations/activities (as needed).
• Serve as backup-up support for OPU Commercial Quality responsible persons on OPU commercial quality operation/activities (as needed).

Requirements:

• Bachelor of Science degree in Chemistry, Pharmacy, Chemical Engineering, Biomedical Degree or related science diploma with relevant work experience.
• Overall minimum of 7-10 years quality experience in pharmaceutical or biologics or medical devices MNC. Any GMP quality experience is a plus.
• Minimum 5 years experience in country commercial quality operation/activities management and execution in pharmaceutical or biologics or medical devices MNC. Any regional commercial quality experience is a plus.
• Thorough knowledge of GDP quality/regulatory requirements with practical expertise in commercial quality operation/activities in pharmaceutical/vaccines/medical devices industry.
• Well-versed in MS Office, Excel and Powerpoint. Familiarity with Go-track, VQD is an advantage.
• Works well in both a team-orientated environment and independently
• Attention to detail, good organizational skills, flexibility
• Sense for urgency and efficiency
• Demonstrates ability to manage multiple activities
• Excellent oral and written communication skills in English language
• Communicates effectively results and project status both internally and externally
• Prepares technical reports including executive summaries and management presentations
• Demonstrates strong analytical skills, is able to judge when more information is needed, where to obtain it and to draw sound conclusions from available information
• Demonstrates mature judgment and strong decision-making skills regarding project and product issues
• Demostrates strong problem-solving skills and is solutions-oriented
• Is able to deal with complexity (critical thinker).