Senior Compliance Specialist (Secondment - 12 Months)

Pfizer•Sanford, NC

12d

About The Position

WHY PATIENTS NEED YOU 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.

Requirements

Applicant must have a bachelor's degree with at least 3 years of experience; OR a master's degree with more than 1 year of experience; OR an associate's 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.

Nice To Haves

Formal experience in the Manufacturing, Technical, or Quality organizations is highly desired.

Responsibilities

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.