Job Description

Commercial Quality Manager, ROPU ASKAN - 234705




OUR COMPANY


At Boehringer Ingelheim we develop breakthrough therapies that improve the lives of both humans and animals. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective.
Now, we are powered by 52,000 employees globally who nurture a diverse, collaborative and inclusive culture. We believe that if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve.

DESCRIPTION

• 
  Contribute to the establishment, continuous improvement and maintenance of the Quality Management System (QMS) in ROPU ASKAN by ensuring that all external (e.g. GMP, GDP, GDPMD, GSP, GIP) and internal BI requirements (e.g. Policies, OCS, OCP, ACP) are implemented at ROPU and each OPU, monitored for performance/adherence and improved, if required.

• 
  Support OPU Commercial Quality (CQ) Managers/Leads, Specialists, Associates and LPCOs) in executing key defined steps in relevant quality processes where such activities are centralized at ROPU.

• 
  Support the Commercial Quality Strategy for the ROPU together with the Head of Commercial Quality ROPU ASKAN and respective Corporate and ROPU Management.

• 
  Support the Head of Commercial Quality ROPU ASKAN in ensuring appropriate Quality oversight related to GMP and GDP/GDPMD/GSP/GIP in the ROPU including:

• Management of external service providers in all quality relevant aspects during the life cycle of a contract beginning with issuance until termination to ensure local supply and manufacture of products or services with acceptable quality, in full regulatory compliance and in accordance with contractual obligations and BI guidelines.
• Performing GMP/GDP/GDPMD/GSP/GIP audits at suppliers and external partners (qualification and regular audit), including follow-up of CAPAs at 3rd parties.
• Implementing/revising relevant GMP/GDP/GDPMD/GSP/GIP quality systems related to commercial product supply in the ROPU to meet the continual needs of the company and the local authorities and ensure that products and processes/systems are delivered to the customers with a consistent high quality standard and in accordance with BI requirements and the local legislations.
• Knowledge management within ROPU by supporting best practice sharing and ensuring training across the ROPU.
• Efficient implementation of standards within the ROPU by maintaining a common document management system; implementation of OCS, OCPs and further Corporate documents; monitor rollout and by standardization of processes.
• Continual quality and compliance improvement within ROPU by identifying optimization potentials and by monitoring OPU performance via self -inspection/self-assessment program.
• Assume role as ROPU system owner (Local MSO), SME, administrator and key user for relevant Quality Systems (E.g.Investigation, CAPA, change control, and product complaints etc).

• 
  Provide support to management/execution of OPU Commercial Quality operation/activties (as needed).
  6. Serve as backup-up support for OPU Commercial Quality responsible persons on OPU commercial quality operation/activities (as needed).

• 
  Provide commercial quality input/support to certain business initiatives, projects, requests as per requirements and established timelines as needed.

• 
  Take on and/or support any other tasks assigned.

DUTIES & RESPONSIBILITIES

• 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 \xe2\x80\x9cORI\xe2\x80\x9d)

• Provide to other local MSO, SME, Administrator, and key users for Quality System Management on above activities if 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).
• 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.
• Represent ROPU ASKAN Commercial Quality team or Head of Commercial Quality ROPU ASKAN to provide input/support for certain business initiatives, projects, requests, matters as per relevant requirements and established timelines as needed.

Requirements:

• 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).
• Ensures Quality and Quality Compliance for Human Pharma and Animal Health products in ROPU ASKAN.
• Bachelor of Science degree in Chemistry, Pharmacy, Chemical Engineering, or related science diploma with relevant work experience.
• 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.
• 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.
• Is able to deal with complexity (critical thinker).

WHY BOEHRINGER INGELHEIM?


With us, you can grow, collaborate, innovate and improve lives.


We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.


In our Regional Operating Unit Asean, South Korea, Australia & New Zealand (ROPU ASKAN) region, Boehringer Ingelheim is one of the fastest growing pharmaceutical companies with over 2,000 employees. We are an equal opportunity global Top Employer who takes pride in embracing diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients, customers, and communities.


Want to learn more? Visit https://www.boehringer-ingelheim.com/

READY TO CONTACT US?
Please contact our Recruiting ASKAN Team: PHI +63 876 6899 | SGP +65 6419 8822 | MYS +603 2092 0041


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Note to Recruitment Agencies:
Boehringer Ingelheim (BI) does not accept candidate submissions from recruitment agencies that BI does not have existing contracts with. BI will not be responsible for payment of recruitment fees for the hiring of candidates whose resumes were submitted to BI employees or BI offices without BI\xe2\x80\x99s prior permission.



Job - Quality/Compliance
Primary Location - Africa, Asia, Australasia-Singapore
Organization - SG-Boehringer Ingelheim Singapore Pte.Ltd
Schedule - Full-time