Your tasks and responsibilities
The primary responsibilities of this role, (Associate Director GLP Qual), are to:
Who you are
- Support direction setting for all strategic aspects within Biologics Development related to GLP aspects;
- Provide management independent assurance whether the respective aspects of non-clinical; development are performed efficiently, accurately, and in compliance with the applicable standards.
- Develop and refine the Local Quality System in Biologics Development (BD) by participating in SOP authorship or review teams. Ensure training of all SOPs on time and to all relevant personnel;
- Lead, plan, prepare, manage and conduct GLP audit activities for non-clinical studies in terms of study plan, SOP-, GLP- and regulatory compliant planning, performance, reporting and thorough documentation, check of quality control measures, preparation of respective audit reports and proposal of improvement measures with focus on Pathogen Safety studies in the test facility Berkeley within Biologics Development;
- Plan, prepare and conduct study, facility and process related onsite audits, preparation of respective audit reports according to applicable SOPs and regulations;
- Support and communicate GLP relevant CSV audit results to and assess/review corrective and preventive actions with all relevant personnel within the test facility including the study directors, study responsible persons and relevant management and other BD functions covered by the audit as applicable in cooperation with the GMP QA department of BD;
- Support Health Authority Inspections conducted at the test facility within BD by providing resources and functional expertise;
- Provide interpretation and guidance for internal and external customers on non-clinical quality related regulations / guidelines (FDA, OECD, ICH, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current GLP standards;
- Conduct training on the GLP audit processes and other processes owned by GLP M for internal and external customers, act as a mentor for less experienced auditors.
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:
- Bachelor's degree in a biomedical or biological sciences or related area;
- 7 years of biopharmaceutical industry experience with at least 5 years in a Quality Management function;
- Broad knowledge in Quality Management in local and global GLP standards (FDA, OECD, EU, MHRA, etc.);
- Training in 21 Basic knowledge of GMP regulations preferably relating to Pathogen Safety studies;
- 3 years proven record in GxP auditing activities;
- Detailed knowledge with all international/regional/local GLP laws, regulations and guidelines;
- Proficiency in 21 CFR Part 58 Good Laboratory Practice and Part 11 Electronic Signature/Records Rule and OECD Standards for GLP;
- Strong communication skills to ensure that audit activities and status are transparent, and that risks, issues, and results are clear to all involved parties, up to senior management;
- Executes his/her responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively;
- Demonstrated experience with escalating project slips/risks/concerns to appropriate stakeholders;
- Ability to navigate different personality styles in a large, complex organization in a professional manner;
- Strong organizational skills with attention to detail;
- Strong written and oral communication skills;
- Self-starter with the ability to juggle multiple priorities while making quick decisions and work independently;
- Ability to make quick decisions taking into account both Bayer and external partner considerations;
- Proficient with Microsoft Suite (Word, Excel, Powerpoint).
#KRT 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:
A little about us:
Why Bayer? Because we’re a pioneer in the fields of human, animal, and plant health. Because we invent solutions that will create a sustainable future for our planet. Because a career with Bayer means you can put your passion into practice and make an impact.