Regulatory Compliance Manager

Johnson & Johnson

4.2

(92)

Schaffhausen, Switzerland

Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.
  • #2506230640W

    Position summary

    sess compliance in failure investigations, root cause identification, action plan development, and effectiveness monitoring.

    • Drive compliance initiatives by implementing proactive projects.

    • Champion Johnson & Johnson Standards and applicable pharmaceutical regulations, ensuring the site's adherence while fostering collaboration across teams.

    • Develop, coordinate, and execute the site's internal audit program.

    • Represent Regulatory Compliance in various forums and promote a culture of continuous improvement through performance metrics and best practices.

    • Collaborate on independent audits and special assessments while refining compliance strategies.

    Qualifications

    Minimum Qualification

    Education:

    • A minimum of a bachelor's degree or equivalent experience in Science or related field.

    Experience and Skills

    Required:

    • Minimum of 7 years in a GMP-regulated environment, with at least 2 years focused on quality, manufacturing or regulatory compliance.

    • In-depth understanding of compliance requirements related to medicinal products

    • Proven experience in preparing and supporting inspections.

    • Strong analytical and interpersonal skills with a solution-oriented mindset.

    Preferred:

    • In-depth knowledge of aseptic technique and large molecule manufacturing

    • Knowledge of small molecule manufacturing

    • Experience performing internal audits (lead auditor certification is a plus)

    Other:

    • Very good communication in English, German skills are a plus.

    • Occasional domestic/international travel (5%-10%).

    This Flex position requires a minimum of 3 days on-site and 2 days remote, with on-site presence needed during audit and inspection periods. Other arrangements can be discussed on a case-by-case basis.

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

    For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit https://www.careers.jnj.com.

    A cover letter is not required for your application, but we kindly ask that you include a brief statement explaining why you are applying in your resume or CV. To ensure a fair recruitment process, please refrain from adding a photo in your CV.

    Why you should apply for a job to Johnson & Johnson:

  • Ranked as one of the Best Companies for Women in 2020
  • 4.2/5 in overall job satisfaction
  • 4.2/5 in supportive management
  • 71% say women are treated fairly and equally to men
  • 88% would recommend this company to other women
  • 85% say the CEO supports gender diversity
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Global parental leave for all new parents (maternal, paternal, adoptive or surrogacy-assisted).
  • Global exercise reimbursement.
  • Two weeks off (one of them fully paid) for volunteer work.