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US_ Sr. Manager, Audits and Inspections

Company: Boehringer Ingelheim
Location: Fremont
Posted on: May 16, 2022

Job Description:

Description:Description\:
Incumbent serves as the subject matter expert (site point of contact/process owner) for client audits/inspections at BI Fremont, leads site inspection readiness activities, client audit/inspection logistics and back room operations.
Drives awareness of GMP requirements, communicates with regulatory and international agencies and ensures industry trends/regulatory requirements are followed at the site. With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities\:

  • Leads and manages activities associated with inspection readiness for BI and client products.
  • Able to document, lead and coordinate commitments and associated corrective actions to health authorities, clients as well as corporate and internal auditors.
  • Prepares for, manages, and leads client audits and regulatory inspections. Works closely with functional groups to prepare for audits and inspections; works closely with functional groups to prepare observation responses and CAPA.
  • Provides guidance regarding remediation activities required to continue production.
  • Provides process and system training for site staff involved in client audit/inspections, balancing training offerings with site demands.
  • Develops training material to ensure a high level of quality, compliance and consistency.
  • Grants, revises and revokes system access to employees.
  • Leads and improves Quality Systems and / or cross-functional Key Performance Indicators.
  • Establish, maintain and improve new and established network alignments (e.g. Corporate, Bio).
  • Lead local/divisional and participates in global process improvement teams.
  • Pro-actively uncover issues and concerns relating to quality systems, and leads resolution and continuous improvement with functional/cross-functional team.
  • Engages local, divisional and global network to ensure alignment with Boehringer Ingelheim standards and related operating units.
  • Provides expertise to the site and division to the audits/inspections.
  • Influences local and divisional network based on knowledge and experience within Quality Systems.
  • Hires and develops talent to ensure support to commercialization and continuous improvement of the Quality Organization.
  • Establishes cross-training activities and back-up efforts within Quality Systems.
  • Annually assesses group tasks and completes accurate resource planning.
    Requirements\:
    • Bachelors degree from an accredited institution, preferably in a sciences or engineering area, with seven (7) years of related biotech/pharma professional experience with cross-functional support/leadership to other cGMP areas; Or
    • Master's degree from an accredited institution, preferably in a sciences or engineering area, with five (5) years of related biotech/pharma professional experience with cross-functional support/leadership to other cGMP areas; Or
    • PhD degree from an accredited institution, preferably in a sciences or engineering area, with two (2) years of related biotech/pharma professional experience with cross-functional support/leadership to other cGMP areas.
    • Certification as a quality auditor (CQA) is desirable.
    • Requires a person who is organized, hard working with a productive work ethic.
    • Ability to make sound decisions with an understanding of the impact of those decisions, provide guidance and mentor junior staff/managers.
    • Ability to lead tasks and priorities in alignment with department, site and divisional drivers.
    • Thorough knowledge and understanding of the relevant current Good Manufacturing Practices (GMP), and guidelines.
    • Knowledge and understanding of practical quality assurance in the manufacturing environment, as well as laboratory controls and safety.
    • The Quality Systems group has an emphasis on process development and optimization, not just system maintenance, therefore the employee must retain flexibility in problem-solving, providing risk-based options towards challenges which may require management review and decision making.
    • Development and delivery of individual and department goals, delivery of site and divisional goals requires a high level of creativity and innovation as well as technical knowledge and organization.
    • Main focus is the local site, however, works with departments from other operational units to leverage best practices.
    • Contributes and leads the completion of cross organizational projects and goals.
    • Must have a strong understanding of the regulatory requirements and compliance standards under which Boehringer Ingelheim Fremont operates; since position require direct participation in BI interactions with various government agencies / regulators as well as external auditors.
      Eligibility Requirements\:
      • Must be legally authorized to work in the United States without restriction.
      • Must be willing to take a drug test and post-offer physical (if required).
      • Must be 18 years of age or older.
        Who We Are\:
        At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.Want to learn more? Visit boehringer-ingelheim.com and join us in our effort to make more health.
        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. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Keywords: Boehringer Ingelheim, Fremont , US_ Sr. Manager, Audits and Inspections, Executive , Fremont, California

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