Manager- Global Quality Lead

    Genpact Published: April 22, 2021
    Location
    London, United Kingdom
    Job Type

    Description

    Manager- Global Quality Lead - LIF005145

    With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it.

    Transformation happens here. Come, be a part of our exciting journey! Are you the one we are looking for? Inviting applications for the role of Global Quality Lead, Pharma Regulatory Affairs
    In this role, you will provide support to the quality lead on all Quality matters to the Regional Operations group and the Company as a whole.

    Responsibilities

    • Provide support to the quality lead on all Quality matters to the Regional Operations group and the Company as a whole.
    • The role will include collaboration with the project managers to define the quality requirements internally.
    • The incumbent will be a strong subject matter expert in Global Quality Assurance requirements, laws, regulations, and guidelines.
    • The incumbent shall be highly collaborative that address all quality and compliance requirements in line with industry and client requirements.
    • The incumbent will ensure assigned groups/teams within the company are aware of the necessary quality standards that must be achieved to ensure successful operation.
    • The incumbent requires strong relationship management and interpersonal skills to partner effectively with key stakeholders and leaders internally and externally.
    • Serves as the point of contact for internal assigned stakeholders on issues related to Quality and Compliance within the operation.
    • Demonstrating individual contributors in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc.
    • Have an understanding of regulatory affairs (EU, USFDA, ROW, etc) requirements for Quality compliance and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
    • Extensive proven experience in various quality functions and departments in the pharmaceutical industry.
    • Have an understanding of QMS activities like annual product quality review report preparation, validation activities, CAPA, deviation, and change control management.
    • Timely updates the QMS records and tracks the same.
    • Have experience in providing training on QMS to other departments.

    Qualifications we seek in you!
    Minimum qualifications

    • B.Sc. / M.Sc.
    • Proven experience with QA compliance and outsourcing initiatives preferably including industry-leading positions within large pharmaceuticals companies
    • Excellent Verbal and Written communication skills
    • Ability to transfer knowledge
    • Ability to engage with people immediately & build Relationship
    • Good client communication
    • Basic project management skills.
    • Mentoring RA team on the Quality requirement
    • Demonstrable knowledge of Quality Assurance and Quality Control and associated procedures and practices within the Healthcare Industry.
    • Proven strategic, project, and client relationship management skills.
    • Proven application of extensive skills in the Quality Assurance environment.
    • Applies extensive knowledge and experience to impact project/function direction.
    • Extensive proven experience in various quality functions and departments in the pharmaceutical industry.
    • Knowledge in regulatory affairs in the generic, biotech, pharmaceutical industry with respective managerial and leadership experience and a thorough understanding of the drug development and lifecycle process.
    • Have faced regulatory audits like ISO, USFDA, EU, Canada, and ROW along with customer audits.

    Preferred qualifications

    • Self-starting ability, Multitasking, Decision making

    What we can offer

    • Attractive salary;
    • Stable job offers - employment contract
    • Work in a multicultural and diverse environment with employees from over 30 countries
    • Genpact supports langauge courses, professional tranings and great career development opportunities
    • Free access to our award-winning learning platform

    Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube

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