Head of Quality

Bora Pharmaceuticals•Maple Grove, MN

7d•$192,000 - $260,000

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. Job Summary Reporting to the VP, Regional Head of Quality, the BPI Site Head of Quality is responsible for developing, implementing, and overseeing a comprehensive Quality Management strategy aligned with corporate policies, client expectations, and global regulatory requirements. This role ensures products from development through commercialization are safe, effective, and fully compliant with applicable CGMP/GxP standards. As a key member of the site leadership team, the Director/Sr. Director of Quality provides strategic and operational leadership for the Quality organization, which includes Quality Assurance and Quality Control. The role partners cross-functionally with all departments to foster a strong culture of quality, accountability, collaboration, and continuous improvement while ensuring regulatory compliance and client satisfaction. The Director/Sr. Director also directs day-to-day quality operations, drives operational excellence and process optimization, supports execution of strategic and tactical initiatives, and ensures timely resolution of quality and compliance issues to maintain business performance and inspection readiness. Essential Functions Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. Provide strategic leadership and overall accountability for the site Quality Management System (QMS), ensuring compliance with global policies, procedures, CGMP/GxP standards, and applicable regulatory requirements across the U.S. and international markets. Partner with the Site Leadership Team (SLT) to strengthen and sustain a proactive culture of quality, escalating significant compliance risks and driving timely, effective resolution of quality issues. Lead and oversee regulatory inspections and audits, ensuring inspection readiness, effective agency interactions, and timely, compliant responses to observations. Direct all core Quality functions, including batch record review, material and product disposition, deviations and change control, document control, QC, QA oversight of all GMP functions including validation, quality engineering, and facility activities. Provide leadership to ensure uninterrupted support for successful product transfers through robust quality oversight and operational excellence. Serve as the senior Quality leader supporting development initiatives and phased clinical programs, ensuring appropriate compliance throughout product development activities. Lead the Quality organization in achieving operational and strategic objectives, including budget planning and management, workforce planning, project execution, and organizational effectiveness. Build, mentor, and develop a high-performing Quality organization that operates as a trusted, collaborative business partner, while driving talent development, succession planning, and employee growth. Establish clear, consistent, and effective communication across the Quality organization and with cross-functional stakeholders to ensure alignment on priorities, risks, and business objectives. Perform additional responsibilities and strategic initiatives as assigned 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 management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Requirements

10+ years of progressive experience within GMP-regulated pharmaceutical and/or combination drug-device manufacturing environments.
Strong working knowledge of global regulatory requirements and quality standards, including US FDA, EMA, PIC/S, and ICH guidelines.
5+ years of senior leadership experience driving Quality strategy, operational excellence, compliance initiatives, and continuous improvement programs.
Proven ability to build and sustain a transparent, collaborative, and quality-focused culture that promotes accountability, engagement, and operational performance.
Demonstrated experience leading cross-functional teams and influencing organizational change within complex regulated environments.
Strong knowledge of pharmaceutical manufacturing operations, including Oral Solid Dose (OSD) processes and associated quality requirements.
Demonstrated success in leading organizations through sound decision-making, strategic problem-solving, and effective communication at all levels of the business.
Proven track record of successfully managing and leading regulatory inspections, audits, and remediation activities with global health authorities.
Exceptional written and verbal communication skills, with the ability to influence stakeholders and communicate complex quality and compliance matters clearly and effectively.
Proven ability to lead, mentor, and support teams through crisis management, organizational transformation, cultural change, and business growth initiatives.
Highly adaptable and resilient, with the ability to perform effectively in fast-paced, high-pressure environments while maintaining focus on priorities and outcomes.
Strong leadership capability with a demonstrated ability to empower teams, identify high-potential talent, and drive employee development and succession planning.
Results-oriented leader with strong analytical and problem-solving skills focused on continuous improvement and operational excellence.
Skilled at building trusted relationships and collaborating effectively with cross-functional peers, senior leadership, clients, and regulatory agencies.

Nice To Haves

Prior experience within a CDMO environment is strongly preferred.

Responsibilities

Provide strategic leadership and overall accountability for the site Quality Management System (QMS), ensuring compliance with global policies, procedures, CGMP/GxP standards, and applicable regulatory requirements across the U.S. and international markets.
Partner with the Site Leadership Team (SLT) to strengthen and sustain a proactive culture of quality, escalating significant compliance risks and driving timely, effective resolution of quality issues.
Lead and oversee regulatory inspections and audits, ensuring inspection readiness, effective agency interactions, and timely, compliant responses to observations.
Direct all core Quality functions, including batch record review, material and product disposition, deviations and change control, document control, QC, QA oversight of all GMP functions including validation, quality engineering, and facility activities.
Provide leadership to ensure uninterrupted support for successful product transfers through robust quality oversight and operational excellence.
Serve as the senior Quality leader supporting development initiatives and phased clinical programs, ensuring appropriate compliance throughout product development activities.
Lead the Quality organization in achieving operational and strategic objectives, including budget planning and management, workforce planning, project execution, and organizational effectiveness.
Build, mentor, and develop a high-performing Quality organization that operates as a trusted, collaborative business partner, while driving talent development, succession planning, and employee growth.
Establish clear, consistent, and effective communication across the Quality organization and with cross-functional stakeholders to ensure alignment on priorities, risks, and business objectives.
Perform additional responsibilities and strategic initiatives as assigned