Director Quality Operations

Job Summary

The Director Quality Operations is accountable for driving quality assurance activities and managing resources to ensure compliance with FDA and other applicable health authority and regulatory requirements. In addition, the Director Quality Assurance provides strategic planning for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities. Finally, the Director, Quality Operations promotes a culture of quality and compliance through effective leadership and demonstrating Bora’s core values.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Functional Leadership

• Facilitate the Quality Management System, including the Quality Manual, and provide an on-going assessment of QMS effectiveness via monthly Quality Management Review meetings with cross-collaboration from each function. Monitor programs / processes for efficacy and recommend improvements.
• In partnership with the Quality Site Head, recommend measures for the Cost of Quality / Cost of Poor Quality (COQ/COPQ) and provide routine status reports to management.
• Monitor and implement quality improvement efforts for greater efficiency and compliance with applicable cGMP regulations. This may include leading system / process engineering or redesign efforts.
• Provide direction to the Quality Management Review process, including analysis and reporting of Quality System performance metrics
• Identify potential compliance gaps and improvement opportunities to ensure effective Inspection Readiness.
• Facilitate the internal audit program, including oversight of audit schedules, plans, and follow-up according to internal procedures, regulatory guidance / expectations, and auditing best practices in alignment with compliance policies and standards.
• Partner with Project Management to strengthen the Client Quality Agreement (QTA) process to ensure consistency with expectations that enhance overall client relationships.
• Provide oversight to the GMP training team to assure direction to assure specific GMP job functions aligned to job descriptions for assigned training.
• Provide oversight to the regulatory inspection team who are responsible for coordination of activities for regulatory inspections (announced or unannounced), reviewing / preparing documentation demonstrating prior commitments were met, identifying areas of potential vulnerability and communicating / mitigating accordingly, and managing logistics for hosting an audit / inspection.
• Coordinate response activities following regulatory inspections including drafting responses, periodic updates (as required), and ensuring adequate follow-up on suggestions for improvement (e.g. FDA EIR notes, recommendations, etc.) within the site quality system.
• In partnership with the Director, Project Management, ensure the Client Audit Program schedules, audit activities and communications to audit response letters are complete.
• Provide input to regulatory inspection responses to ensure systemic, comprehensive solutions address root causes and prevent recurrence.
• Develop, coach, and mentor team members to achieve organizational goals and business excellence.
• Optimize resources and build team effectiveness to create efficiencies and synergies.
• Demonstrate accountability and promote core values through leading the team by example in overcoming challenges to key deliverables.
• Lead the quality team through hiring, assessing, training and developing talent. Responsible for executing succession planning for the department
  
  

External Stakeholders

• Act as the negotiator with regulatory agencies on quality related matters, involving and coordinating with the business to maintain, resolve or improve company’s compliance standing.
• Advocate for the customer and influence senior management on critical customer issues.
  
  

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Iii. Minimum Education, Experience, Skills

• Bachelor’s degree in Science, Pharmacy, Engineering, or related field. A Master of Science Degree would be considered an asset.
• A minimum of ten (10) years in a senior management position in Quality or Regulatory. Proven ability to independently manage issues regarding regulatory compliance, product acceptability, risk assessment and functional operations.
• Ability to maintain an enterprise mindset and to apply an organizational lens to departmental decision making.
• Excellent communication, negotiation, interpersonal skills, management and organizational acumen.
• Demonstrate a strong commitment to teamwork, empowerment and innovation to drive performance.
• Ability to build, maintain and navigate relationships with stakeholders at all levels of the organization, such as negotiating with stakeholders and influence senior level leaders regarding matters of significance to the organization.
• Translate technical details, regulatory and quality standards and business judgment into concrete requirements and actionable priorities.
• Navigate decision making through the lens of cycles of cause and effect analysis, corrective actions and prevention.
  
  

Compensation Range

$162,233.00 - $243,350.00

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Injectables, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category