Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Associate Director Quality Assurance Site Compliance and Learning

Your tasks and responsibilities

 

The primary responsibilities of this role, Associate Director Quality Assurance Site Compliance and Learning, are to: 

 

  • Accountable for the internal audit/self-assessment program;
  • Ensure that audits are performed per developed schedule;
  • Review findings and makes recommendations for remediation;
  • Ensure timely responses and closure of all action items / commitments;
  • Determine the ability of departments to meet regulatory compliance requirements through the Bayer CMS;
  • Provide QA/regulatory compliance interpretation to department managers and other organization leaders and leads the regulatory intelligence program to stay ahead of health authority expectations and emerging trends;
  • Provide site leadership for the Quality Management Review (QMR) program;
  • Ensure that all relevant data is presented to Site Leadership;
  • Provide appropriate metrics and trending analyses;
  • Ensure corrective action follow-up;
  • Serve as an organizational leader in preparing for and maintaining standards for regulatory agency inspections of the Supply Center;
  • Lead the preparation of written, detailed responses in response to on-site or other audits, inspections and surveys;
  • Accountable for the organization, compilation, editing, and preparation of the annual product reviews and reports with descriptive statistics and data presentation in chart and graphical forms;
  • Provide effective leadership in cGMP compliance related training and learning management;
  • Lead a team of learning experts who administer the Learning Management System, new hire onboarding and annual GMP training;
  • Provide effective personnel leadership including: selecting key personnel and motivating members of the functional area; assist with Performance Calibration/Talent Pool Management; individual goal setting/performance reviews; managing the development of employees.

     

Who you are

 

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’s Degree in a scientific or technical field, preferably in the biological sciences; 
  • Ten years of GMP related experience in pharmaceutical, biologics, medical device, or related industry, along with knowledge of applicable US and foreign regulations; 
  • At least six years of direct experience in Manufacturing and/or Quality and people management in a GMP-regulated industry or an equivalent combination of education and experience;
  • Expertise in GMP compliance and FDA/EMA regulations (21CFR4, 210/211, 820), ICH Q10, IS0 13485, global regulations (EU Directives, and ROW) and in the cGMP requirements pertaining to manufacturing operations in the United States in support of commercial production activities;
  • Ability to correctly interpret minimum standards is a must;
  • Track record of identifying and implementing updates to internal policies and practices based on changes in the regulatory landscape;
  • Demonstrated ability to support regulatory activities and obligations to Health Authorities;
  • Attention to detail as well as a crisp, clear and concise style in written and oral communications with strong presentation and influencing skills;
  • Demonstrated ability to work independently and flexibly in a fast-paced, complex  environment;
  • Experience successfully leading health authority inspection readiness activities, annual product review and/or Quality Management Review meeting;
  • Excellent people skills to convince, motivate and encourage customers/stakeholders to understand and accept his/her recommendations, especially with borderline issues;
  • Proven ability to express views and opinions, listens well and accept conflicting points of view;
  • The ability to independently recognize opportunities and the need for business and process improvements;
  • The ability to multitask and support changing priorities;
  • The position requires broad knowledge of biotech/pharmaceutical product life cycle and manufacturing (e.g., product development, fermentation/cell culture operations, purification operations, fill/finish/packaging, distribution, validation);
  • Advanced technical writing abilities including advanced knowledge of word processing software functions and capabilities (e.g., MS Word);
  • Proven ability to collaborate across functional boundaries and provide strategic guidance in the preparation of quality-related regulatory documentation;
  • Familiarity with change control and regulatory affairs processes for regulated industries;
  • Familiarity with adult learning theory and learning management systems.

 

Preferred Qualifications:

 

  • An advanced degree is preferred;
  • Experience in authoring/reviewing of CMC submissions is highly desired.

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. 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.

 

Country: United States
Location: CA-Berkeley
Functional Area:
Entry Level: