Pfizer Regulatory Compliance Lead in San Diego, California
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
Educational Background: BS in related field required; MS preferred. CPIA certification required.
• In general, a colleague at this level will have a minimum 3-5 years of IACUC and regulatory experience.
• Experience in a biomedical research setting, with a working knowledge of animal facility operations and regulatory requirements governing animal research.
• Ability to function independently with minimal supervision and the capacity to expand areas of expertise and learn new skills to meet changing needs.
• Excellent organization skills, including scheduling, follow-up, and attention to detail.
• Excellent interpersonal skills and a cooperative and communicative nature.
• Excellent verbal and written communication skills, including proficiency with a variety of computer systems.
• Direct experience in animal welfare oversight, quality assurance, and IACUC functions.
• Comprehensive knowledge of regulations and guidelines pertaining to animal care and use in a research setting.
• Strong analytical and creative problem-solving abilities.
• Experience working collaboratively in committees to achieve results.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May be required to work under one of the following: the United States Department of Agriculture Animal Welfare Act and associated Regulations and Standards, the Guide for the Care and Use of Laboratory Animals, Good Laboratory Practices, Public Health Service Policy and/or AAALAC accreditation standards.
• Audit and evaluate systems, operations, and/or processes for compliance with appropriate SOPs and regulatory requirements, including writing and following up on PAM reports.
• Track and report on observed quality and compliance trends in the areas inspected.
• Identify and communicate opportunities for continuous improvement in ongoing activities based on audit/inspection findings.
• Facilitate the smooth and efficient operation of the site IACUC and related subcommittees, including facilitating animal use protocol review using a web-based system, coordinating and documenting IACUC meetings and semiannual reviews, and record-keeping
• Participate in regulatory inspections/site visits as needed, including maintaining the AAALAC Program Description
• Develop and maintain SOPs/guidelines and propose changes to current practices and policies as appropriate
• Assist investigators in understanding IACUC expectations and in the writing and preparation of animal use protocols; Provide expertise and interpretation of animal welfare regulations to investigators as needed.
• Oversee all activities related to the post-approval monitoring (PAM) program; including scheduling, coordinating, participating in, documenting, and ensuring follow up on all PAM activities.
• Develop, implement, and provide effective regulatory educational programs for members of the animal care and use program.
• Develop and implement a robust document control process, including SOP management, versioning, document retrieval during audits/inspections, and archiving.
• Serve as representative on local, site, and global teams.
• Provide backup support for the day to day management of the animal use protocol review process, using web-based protocol tracking system.
Influence and ensure overall success of regulatory compliance within the site and alignment with global CM and WRD regulatory endeavors. Assist in all aspects of animal research compliance as needed, with a primarily focus on quality assurance and IACUC coordination. Influence and ensure overall success of Continuous Improvement within the site in alignment with global CM and WRD endeavors. Ensure tactical execution of global CM Strategic Imperatives.A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.