Senior Manager, Quality Assurance - Compliance

Position Summary

This position is responsible for managing various aspects of the quality management system and assisting senior leadership.

Position Reports to:

Vice President of Quality Assurance

Position Supervises:

QA Manager, Compliance; QA Compliance Specialist, Document Control Associates

Essential Duties and Responsibilities

The essential functions include, but are not limited to the following:

• Lead EQMS Systems including but not limited to Investigation, CAPA, Audits, Customer Complaint and SCAR
• Oversee the investigation and resolution of non-compliant events and CAPAs, including all operational discrepancies and customer complaints.
• Oversee Training and Document management Team
• Lead Training and development activities
• Lead document management processes and improvements
• Work with respective departments relevant to issues being investigated in non-compliant events
• Provide data, analysis and present Right First Time (RFT) data
• Oversee the CAPA program
• Oversee the Change Management program
• Oversee the Environmental Monitoring program
• Perform final release of clinical supplies as needed
• Perform quality improvement assessments and initiate changes to the quality management system
• Supplier Approval Program Lead/ Perform and/or participate in supplier audits
• Participate in client audits and health authority (FDA) inspections
• Oversee Internal Audit Program
• Lead Perform and/or participate in internal audits
• Approval of validation documents
• Lead QRB Meeting and processes
• Track and compile metrics of the quality system for reporting at Quality Review Board (QRB) meetings.
• Manage the Quality Compliance team members
• Other duties as assigned

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor’s degree or equivalent work experience
• Excellent interpersonal skills including working across teams
• Excellent English reading and writing skills
• Excellent English communication skills
• Ability to prioritize and manage multiple projects across teams
• Excellent problem-solving skills and coordination across teams
• English literacy
• General mathematical skills
• Computer literacy skills including the Microsoft Suite
• Attention to detail
• Familiarity with cGMPs
• Familiarity with the pharmaceutical industry
• Managerial experience
• Leadership skills

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee may occasionally need to lift and/or move up to 30 pounds. While performing the duties of this job, the employee is exposed to an office environment and occasionally exposed to the warehouse and operations (packaging) environment including occasional exposure to elements such as odor, noise, dust, heat, cold or chemicals. The noise level in the work environment is usually moderate.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.