Job Description

Job Title Quality Manager PQM META

Description

- Quality Manager 3PQM META (2211631)

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment which benefits our employees, patients and communities.

Quality Manager 3PQM META - 2211631

Quality Manager Third Party Quality Management (3PQM) - Middle East Turkey and Africa (META)

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.

THE POSITION

We are hiring a Quality Manager, Third Party Quality Management (3PQM) for META (Middle East, Turkey and Africa) based in Dubai.

The successful candidate will be responsible for Quality management of all third-party manufacturing activities at Third Party Manufacturers (CMOs\out-licensees) and the related products assigned to Third Party Quality Management (3PQM) META group in line with current GMP and relevant regulatory requirements.

The identified candidate will ensure that the quality management system is being followed and maintained within Third Party Manufacturing (3PM) META in line with the Boehringer Ingelheim (BI) Pharmaceutical Quality System (PQS) and regulatory expectations.

The position reports directly to the Head of 3PQM IMETA.

Tasks & responsibilities
Act as overall Quality responsible for the assigned Third-Party Manufacturers overseeing and resolve relevant quality issues at CMO\out-licensees and ensure compliance with BI quality requirements throughout the contract life cycle
Support the Business in the assigned region by representing 3PQM META in technology transfer projects, negotiating and setting up quality relevant contracts (quality agreements) and quality oversight of the routine manufacturing phase to support product launches and new business opportunities.
Ensure regulatory compliance and high-quality standards of products manufactured at the assigned Third Party Manufacturers
Maintain full product quality risk oversight and proactively drive risk reduction programs at the assigned Third-Party Manufacturers in addition to support the product quality review (PQR).
Obtain and report Key performance indicators and act accordingly. Identify risks, propose, and implement risk mitigation measures
Management, timely reporting and follow up of deviations, CAPAs, customer complaints, change controls related to BI products at the (C ontract Manufacturing Organisation) CMOs/internal and ensure that effective root cause analysis is conducted and that the CAPA process at the Third-Party Manufacturers is implemented effectively
Provide support to all activities associated with product recalls according to the BI Quality requirements and local procedures
Contribute to the Quality Management Review (QMR) meeting of 3PQM META; and present relevant Quality topics from as required
Lead the quality expert meetings, annual Third-Party Manufacturers quality rating and participate in Business Review Meeting
Write, update and review SOP's and ensure congruence with good manufacturing practice (GMP) and BI PQS and quality manual
Support the update and maintenance of the Quality system and ensure that it is applied and that all activities are performed according to the local Quality System and SOP's
Act as local management system owner and/or key user for the assigned quality systems. And provide GMP training as required
Support inspection readiness activities and support BI quality audit
The role holder is expected to travel up to 40 - 50 % of the work time
Requirements
Bachelor's degree in Pharmaceutics, Chemistry or Biopharmaceuticals
8-10 years of relevant experience in the pharmaceutical manufacturing environment including Quality Assurance and Quality Control expertise with demonstrated ability to interpret and implement international pharmaceutical GMP requirements
Experience/ability to manage Quality at Third Parties (experience in Third party contract manufacturers is preferred)
Good knowledge of Quality Systems and hands on experience in overseeing GMP requirements in pharmaceutical manicuring
Demonstrated experience in change management, management of customer complaints, deviations, conducting investigation, root cause analysis and CAPA management and follow up
Demonstrated experience in equipment and process Validation
Should possess a strong attention to details with experience in driving quality performance in a commercial environment while maintaining a quality-focused attitude
Demonstrates fluency in English, oral and written communication skills, and interpersonal skills in international environment
Must possess strong analytical and problem-solving skills
Project Management experience is highly desirable
Good working knowledge of Microsoft office with demonstrated skills in the use of information management systems in a highly regulated environment (e.g. Trackwise, SAP)
Results driven with excellent customer and quality focus
Strong ability to coach and motivate people and manage people without direct authority
Ability to make decisions, evaluate risks & define and execute an action plan
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.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.
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