Senior Compliance Specialist
Senior Compliance Specialist
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Job Description
Use Your Power for Purpose
Everything we do every day is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible innovative and customer oriented. Whether you are involved in development maintenance compliance or analysis through research programs your contribution will directly impact patients.
What You Will Achieve
This position reports to the Manger of Operations Compliance at the Sanford site. The position is responsible for maintaining compliance inspection readiness cGMP auditing manufacturing CAPAs manufacturing change controls commitments (PQS audit response and CAS reports) manufacturing risk assessment facilitation and interactions with internal and external Regulatory agencies (FDA EMEA etc.) Key focus is the oversight quality related requirements for operations areas and executing tasks to ensure full cGMP compliance.
The Senior Compliance Specialist is accountable for supporting manufacturing functions to optimize compliance and productivity across Sanford Operations. Working in strong partnership with Engineering Maintenance & Utilities (EMU) Technical Services Quality EHS and Operational Excellence. This SME will provide core support to the overall compliance and success of the 24/7 operations team. Will accompany internal and external Regulatory auditors and interact with agencies during cGMP inspections. Will provide and assist in audit responses.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Change control ownership for operations
Manufacturing ownership for CAPAs
Manufacturing risk assessment facilitation
System administrator for data integrity reviews and account recertifications
Audit readiness and responses
Manufacturing point of contact for commitments
Ensuring compliance with Standard Operating Procedures (SOPs) current Good Manufacturing Practice regulations (cGMP) and corporate policies and safety practices
Focus on Safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
Self-motivated and able to adapt to rapidly changing priorities.
Strong oral and written communication skills.
Participate in and may take a lead in decision making process.
Engage and inspire their team members on performance expectations and coach the team to meet those expectations using Coaching Skill principles.
Lead and support continuous improvement efforts where applicable.
Be a role model to support a positive compliance culture.
Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or Data Integrity principles.
Here Is What You Need (Minimum Requirements)
Applicant must have a bachelors degree with at least 2 years of experience; OR a masters degree with 0 years of experience;
OR an associates degree with 6 years of experience; OR a high school
diploma (or equivalent) and 8 years of relevant experience.Demonstrate experience in compliance project management and system administration in a multi-layered organization Experience in two of the following areas is desired: Manufacturing Materials Management/Planning QA QC Technical Services and Engineering.
Bonus Points If You Have (Preferred Requirements)
Formal experience in the Manufacturing Technical or Quality organizations is highly desired.
PHYSICAL/MENTAL REQUIREMENTS
Job will require regular walks and observations within the manufacturing facilities.
Non-Standard Work Schedule Travel or Environment Requirements
Nonstandard work schedule may be required to support site regulatory inspections.
OTHER JOB DETAILS
Last Date to Apply for Job: August 27 2025.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: NO
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
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. This position requires permanent work authorization in the United States.
Pfizer endeavors to make to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing please email. This is to be used solely for accommodation requests with respect to the accessibility of our website online application process and/or interviewing. Requests for any other reason will not be returned.
Required Experience:
Senior IC
Employment Type
Full-Time
