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Prin Spec QRM

Company: Bayer
Location: Berkeley
Posted on: January 12, 2022

Job Description:

At Bayer we 're visionaries, driven to solve the world 's toughest challenges and striving for a world where ,Health for all, Hunger for none ' is no longer a dream, but a real possibility. We 're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining -impossible '. There are so many reasons to join us. If you 're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there 's only one choice.

Prin Spec QRM


The primary responsibilities of this role, Principal Specialist QRM, are to:

  • Be responsible for the implementation and maintenance of the contamination control strategy within the quality risk management program in a supply center that manufactures biotechnology derived drug products;
  • Act as team lead for the contamination control portion of the quality risk management program;
  • Identify, design, and recommend control enhancements, operations improvements, personnel training, and other corrective actions as appropriate;
  • Participate in the defense of the overall environmental control program to regulatory agencies;
  • Support validation and change control activities related to facilities and utilities;
  • Provide input into investigations and deviations involving suspect equipment, utility or facility failures resulting from EM activities;
  • Provide Quality oversight and guidance to internal and external customers to ensure a compliant EM program and to ensure the program is consistent with company procedures;
  • Assist in the development and preparation of regulatory submissions related to the environmental quality of manufacturing facilities and processes;
  • Collaborate with departments to ensure that EM activities are executed efficiently for non-routine environmental monitoring (EM) activities;
  • Serve as a subject matter expert (SME) and resource for internal and external customers on EM principles and standard practices;
  • Utilize expert knowledge in developing, implementing and maintaining risk-based contamination control systems and standards to implement a robust and compliant strategy that satisfies regulatory scrutiny required to introduce new products and maintain existing products in a compliant state;
  • Manage the scheduling, resource planning and execution work required to implement and maintain these strategies, this includes ensure the systems are in place for tracking risk mitigations;
  • Ensure consistent application of the requirements and strategies in the supply center;
  • Support the compliance element for contamination control within the quality risk management program for the site;
  • Manage the planning, coordination, and management of contamination control strategies related to new, modified, and existing facilities and systems;
  • Manage cross-functional teams to ensure timelines and key milestones are met within compliance with corporate directives and regulatory expectations;
  • Define deliverables and standards required to implement the overall quality risk management program contamination control strategy and make improvements throughout the product lifecycle;
  • Identify of risk-based approaches from product development to product launch;
  • Establish/Inform procedures and methods to ensure contamination control strategy is applied;
  • Define overall contamination control strategies for the product;
  • Ensure the creation of risk management documentation to support contamination control strategies;
  • Facilitate complex and/or highly visible/critical Risk Assessments using defined methods such as Failure Mode and Effects Analysis (FMEA), Hazard Analysis and Critical Control Points (HACCP), Risk Based Impact Assessment implementation plans, risk assessments and risk assessment status lists;
  • Act as quality approver for HACCP assessments generated for facilities;
  • Be responsible for driving strategic program deliverables and generating updates on program status for local and global Quality Management Reviews levels of technical performance for others to emulate.


    Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:

    Required Qualifications:

    • Bachelor of Science in Engineering, Biology, Chemistry, Biochemistry or related field with a t least 10 years of Pharmaceutical and/or Biotechnology experience including quality risk management, facility, utility, equipment/ systems and process experience, or an equivalent combination of education and experience;
    • Advanced knowledge and experience in biopharmaceutical subject matter areas including Manufacturing of bulk, intermediates and final containers, Product disposition and release, Discrepancy management, Product inspection and labeling, Aseptic processing, Environmental monitoring, Contract manufacturing;
    • Advanced knowledge in environmental monitoring and contamination control practices;
    • Broad cGMP experience and knowledge, QA/QC and regulatory compliance (U.S. and other international agencies);
    • Ability to streamline business processes to maximize efficiencies to resolve discrepancies and trending issues;
    • Be able to make tough decisions under pressure and be able to adapt to changes in organization structure;
    • Strong leadership and interpersonal skills;
    • Skilled in achieving results and leading others through influence to achieve corporate, site, and departmental objectives;
    • Excellent communication skills, good presentation and influencing skills;
    • Ability to interact and gain the support of senior management;
    • Ability to effectively manage multiple, complex priorities;
    • Ability to work cooperatively in teams and peer relationships;
    • Proficiency in spoken and written English language;
    • Proficiency in Microsoft Word applications;
    • Knowledge of compliant, risk management program elements;
    • Demonstrated experience with risk management tools such as FMEA, hazard and control point analysis (HACCP) and fishbone analysis;
    • Demonstrated ability to successfully implement contamination control strategy elements for new and/or legacy biopharmaceutical manufacturing processes;
    • Advanced working knowledge of cGMP as it relates to risk management;
    • Knowledge of quality systems including how risk management interfaces with key elements of the overall quality system;
    • Knowledge of international regulations, compendia, industry guidance and regulatory requirements related to quality risk management and compliance;
    • Demonstrated ability to generate program documentation that provides practical, specific, clear, implementable and compliant guidance to the business;
    • Knowledge of risk management and risk analysis tools e.g. ICH 8, 9, 10, as they are applied to integration of risk management in the overall quality system;
    • Ability to influence across multiple departments and sites, including senior management levels of the organization;
    • Ability to solve complex problems requiring in-depth technical, scientific and engineering knowledge, in a compliant manner and under pressure of timelines;
    • Demonstrated ability to foster strong interpersonal relationships and collaborate with a diverse group of colleagues;
    • Lead by example, exhibits impeccable integrity, flexibility and efficiency;
    • Exceptionally strong written and verbal communication skills.

      Preferred Qualifications:

      • Experience executing HACCP risk tool in pharmaceutical/biotechnology function;
      • Knowledge of risk management in Contract Manufacturing Operations. YOUR APPLICATION
        Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.
        To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

        Bayer is an Equal Opportunity Employer/Disabled/Veterans

        Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.
        IMPORTANT NOTE for POTENTIAL US CANDIDATES: Bayer active employees are required to disclose their vaccination status and if fully vaccinated, provide proof of vaccination status before participating in approved activities for fully vaccinated employees. Bayer defines fully vaccinated in alignment with CDC which is two weeks after completing the two-dose vaccine regimen or two weeks after completing the one-dose regimen. Additionally, if candidates are invited on site as visitors for in person interviews, they must provide proof of being vaccinated and comply with all safety protocols. Location: United States : California : Berkeley Division: Pharmaceuticals Reference Code: 504706 Contact Us Email:

        Job Segment: Biochemistry, Biotech, Engineer, Law, Quality Manager, Science, Engineering, Legal, Quality

Keywords: Bayer, Berkeley , Prin Spec QRM, Other , Berkeley, California

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