Sr. Compliance Specialist

About the Role

This position will be responsible for Quality Compliance Oversight, Quality Council Management Review, Site Compliance Metrics, Knowledge Management, Site Inspection Readiness program, Internal Audit program, Partner Management activities, and Supplier Qualification and Vendor Management program. The position is responsible for the development and monitoring of corrective action plans related to trends identified from inspection and audit observations.

Responsibilities

• Prepare and support communication of site quality system status through management review forums.
• Manage Quality Technical Agreements (QTA) with internal and external partners to ensure compliance.
• Lead and execute internal audits to verify adherence to pharmaceutical manufacturing regulations.
• Coordinate and manage external audits/inspections, including timely responses and CAPA tracking.
• Oversee Inspection Readiness program to maintain site preparedness.
• Collaborate with Site Operations and Quality Management to resolve compliance issues promptly.
• Conduct Knowledge Management activities, including regulatory review and gap assessments.
• Support investigation reviews and corrective action plans, ensuring proper documentation and notification.
• Manage vendor/supplier qualification and related compliance activities.
• Ensure periodic document reviews and gap assessments for department and site compliance.
• Own and update procedures for assigned responsibilities.
• Lead special cross-functional projects and present findings to senior management.
• Complete required training and maintain compliance with all assignments.
• Maintain work areas and perform duties safely and efficiently in accordance with company policies, cGMPs, SOPs, and Batch Records.
• Responsible for performing additional related duties as assigned.

Qualifications

• Bachelor's Degree, preferably in a scientific or engineering discipline, or equivalent education/experience with a minimum of 7 years relevant progressive experience in the pharmaceutical or related industry.
• Strongly prefer a minimum of 3 years performing audits and measurements of GMP Quality Systems, preferably in the pharmaceutical industry.
• Requires experience and knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Working knowledge of FDA, EMA, DEA, EPA and other regulatory requirements for a research and commercial environment.
• Experience providing support for regulatory agency inspections preferred.
• Experience with writing and negotiating Quality Technical Agreements preferred.
• Experience in a pharmaceutical manufacturing environment preferred.
• Experience with internal/external auditing is preferred.
• ASQ CQE/CQA Certification (or equivalent) is preferred.

Skills

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, TrackWise, Veeva, and Qdocs.
• Ability to manage multiple priorities and reporting requirements.
• Ability to motivate and influence others with and/or without direct supervisory authority.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and internal/external partners.
• Detail oriented with ability to analyze information, develop possible solutions, create metrics and articulate the link to business needs/objectives.
• Project management and advanced presentation skills.
• Self-directed with ability to organize and prioritize work.

Working Environment

• Exposure to low noise levels in an office environment.
• Occasional exposure to moderate to loud noise levels.
• Occasional exposure to moving mechanical parts or equipment.
• Required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).

Benefits

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Employee Assistance Program
• Employee Stock Purchase Plan
• Tuition Assistance
• Flexible Spending Accounts
• Health Savings Account
• Life Style Spending Account
• Volunteer Time Off
• Paid Parental Leave (if eligible)
• Family Building Benefits
• Virtual Physical Therapy
• Accident, Critical Illness and Hospital Indemnity Insurances
• Identity Theft Protection
• Legal Plan
• Voluntary Life Insurance and Long Term Disability

This response is AI-generated, for reference only.