Compliance Specialist III

Reports To: Associate Director, Compliance

Core Essential Skills – Minimum 5 years of experience:

• GMP Quality Systems and Regulatory Compliance Experience
• Internal & External Auditing and Inspection Readiness
• CAPA, Investigations, and Compliance Issue Resolution
• Quality Documentation Review and Quality Technical Agreements
• Independent Problem-Solving, Sound Judgment, and Cross-Functional Communication
• Candidates should be senior-level, independent, motivated, and comfortable making higher-level decisions.
• Experience with compliance or quality systems, documentation review and approval, and strong technical writing skills. Management experience is not required.

POSITION SUMMARY:

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.

ESSENTIAL AREAS OF RESPONSIBILITY:

• All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.
• 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.

POSITION REQUIREMENTS:

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience:

• 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/Knowledge/Abilities:

• 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.

Problem Solving:

• Proactively works on problems of a moderate to complex Product where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
• Seeks out all resources when selecting methods and techniques for obtaining results.
• Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

PHYSICAL REQUIREMENTS:

Constant:

Sitting for extended periods of time at workstation or mobile equipment.

Using fingers to perform activities such as picking, pinching or typing.

Frequent:

Repetitive Motions – frequent motions of the wrists, hands and/or fingers.

Walking to move short distances quickly and frequently.

Occasional:

• Twisting/Reaching – turning at waist and extending hands and/or arms in any direction.
• Pushing and/or Pulling – using upper extremities to exert force.
• Grasping – applying pressure to an object with the fingers and palm.
• Lifting – raising from lower to upper and/or moving objects Clienttally up to 25 lbs.

Visual Acuity:

Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

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.)