Director, Quality Assurance - API Drug Development - Madison, WI
Do you have Quality System experience in API drug development and a passion for mental health treatment? This could be the perfect leadership role for you!
What You'll Do:
The Director, Quality Assurance is responsible for the strategic development and execution of the quality assurance program including all quality-related decisions. This position reports to the Founder and Executive Director for the execution and administration of all GXP Quality Systems and is directly accountable for cGMP, GLP, GCP and GVP compliance in accordance with ICH, US, EU, and other relevant regulations. This role is expected to lead a team and collaborate across the organization on all quality matters and develop strong relationships with external consultants and contractors as necessary to support QA activities and responsibilities. The opportunity requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) and relevant regulations across multiple jurisdictions. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing the company's impact within its field of research.
Key Responsibilities: Ensures that the Quality Management System meets standards expected by US and global regulatory authorities for research, development, and ultimately commercial activities. Ensures quality metrics comply with best industry standards and practices. Maintains effective quality governance and continually improves governance to meet organizational and compliance needs. Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions. Establishes strong working relationships with external product manufacturers and assures alignment of Quality Management Systems and requirements with these CMOs. Ensures that products manufactured at CMOs meet organizational quality standards and government regulations. In collaboration with Clinical team, provides appropriate quality oversight of CROs. Establishes, maintains, and leads oversight of internal Quality Management Systems. Continually evaluates and improves quality-related initiatives, priorities, and timelines. Ensures that appropriate quality criteria are built into the selection/implementation of, and upgrades to, electronic systems used to support any GXP related activities. Provides leadership and mentorship to the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met. Keeps abreast of industry developments, forthcoming regulations, guidance, best practices, etc. Interprets and applies quality requirements and provides guidance and training to ensure that the company and its GxP vendors maintain an ongoing state of compliance. Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to the Leadership Team. Serves as an escalation point for organizational compliance and quality issues. Serves as a primary contact in any audit by a regulatory authority and leads all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management. Conducts all duties in compliance with country-specific regulations, applicable SOPs, and other applicable guidelines. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others. Embraces and is open to incorporating the Emotional & Social Intelligence (ESI) core principles in daily work. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
What You'll Bring:
Bachelor’s degree, preferably in the life sciences. 15+ years of relevant experience in GXP, QA leadership positions in a Biotech and/or Pharmaceutical industry. Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities. Familiar with ICH Quality Guidelines and a demonstrated ability to utilize ICH Q9 / Quality Risk Management principles in everyday practice. A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members. Proactive in identifying opportunities with a strong solution-minded approach and flexibility to emerging challenges based on the scope and growth of the organization. Strong collaborative, influencing, and interpersonal skills Excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management. Ability to prioritize competing activities, manage resources, and budget accordingly.
Ideal Qualifications (Not required) Master’s Degree Experience/familiarity with regulations related to controlled substances Proficiency with Microsoft Word, Excel, and Outlook.
Apply Now and move your career forward with a great team and non-profit leader in mental health! Questions? Contact Andie Veach directly at Andie@CarexScientific.com
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.