Vice President, Quality

The Vice President of Quality Assurance (QA) plays a pivotal leadership role in ensuring compliance, quality, and safety standards across multiple sites of QuVa’s 503B Outsourcing Facilities, specializing in compounded sterile preparations. The VP, Quality will be responsible for establishing and maintaining a robust quality management system while providing strategic direction to ensure all products meet regulatory and industry standards across all facilities. The VP, Quality will oversee the Corporate Quality department that is transformational in steering the Quality culture and compliance to the site Quality and Manufacturing departments.

Responsibilities May Include

Oversees all aspects of Corporate Quality Assurance:

Quality Management System (QMS)

• Develop, implement, and maintain a comprehensive QMS to meet all regulatory requirements and industry best practices across all sites
• Oversee the creation, review, and approval of Standard Operating Procedures (SOPs) related to quality assurance
  
  

Multi-Site Compliance

• Ensure that all sites operate in full compliance with cGMP, FDA, and other regulatory agencies
• Implement standardized quality processes and procedures across all sites
  
  

Regulatory Compliance

• Stay abreast of all relevant regulations, guidelines, and industry standards related to 503B Outsourcing Facilities, parenteral injectables, and quality assurance
• Oversee compliance efforts at all sites, including coordination of inspections and audits
  
  

Audit And Inspection Management

• Coordinate and manage internal and external audits and inspections across all sites
• Implement corrective and preventive actions (CAPA) in response to audit findings
  
  

Product Quality Oversight

• Provide leadership maintaining and establishing quality standards across all sites
• When applicable, lead investigations and resolution of product quality issues
  
  

Training And Development

• Develop and oversee training programs for corporate quality assurance personnel
• Foster a culture of quality consciousness and continuous improvement across all sites
  
  

Risk Management

• Identify and assess potential quality and compliance risks at all sites
• Develop and implement risk mitigation strategies
  
  

Documentation And Record Keeping

• Oversee the maintenance of accurate and complete documentation and records related to quality assurance activities at all sites following the ALCOA principles
• Ensure Data Integrity with computerized systems and equipment across all sites
  
  

Management Responsibilities

• Mentor and develop staff, managing work allocation, training, problem resolution, performance evaluation, and the building of an effective team dynamic
• Build, develop, and lead a high-performing Quality Assurance team across all sites
• Provide mentorship and guidance to team members
• Responsible for managing overall staffing levels
• Provide oversight and direction to QA employees in accordance with the organization’s policies and procedures
• Lead QA employees to meet the organization’s expectations for productivity, quality, and goal accomplishment
• Manage the overall Corporate QA operational, budgetary, and financial responsibilities and activities
• Work with Human Resources in interviewing candidates as necessary
• Actively participate in QA performance evaluations
• Participate as needed in customer/potential customer tours and orientations
• Participate in regulatory and accreditation activities as required
• Lead by example
• Other duties as assigned
  
  

Qualifications

• Legally authorized to work in the job posting country
• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Pharmaceutical Sciences, or related field required
• Minimum of 15 years’ experience in quality assurance within the pharmaceutical industry, with specific experience in parenteral injectables and aseptic filtration sterilization
• 5-10 years’ successful leadership experience in quality assurance, including experience with audits and regulatory inspections
• In-depth knowledge of cGMP regulations, FDA guidance, and other relevant quality standards
• Experience in the direction and implementation of quality procedures; auditing, project management inclusive of organization, delegation, and change management
  
  

To Be Considered

In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.

Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.

It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.