Job Description

Primary Function

DiaMedica is a clinical stage biopharmaceutical company bringing their lead candidate, DM199, through clinical development.

DM199 (rinvecalinase alfa) is a synthetic form of human tissue kallikrein-1 (rhKLK1) in clinical development for acute ischemic stroke and preeclampsia. KLK1 is a serine protease enzyme that plays an important role in the regulation of diverse physiological processes via a molecular mechanism that increases production of nitric oxide, prostacyclin and endothelium-derived hyperpolarizing factor. In the treatment of preeclampsia, DM199 is intended to lower blood pressure, enhance endothelial health and improve perfusion to maternal organs and the placenta. In the treatment of AIS, DM199 is intended to enhance blood flow and boost neuronal survival in the ischemic penumbra by dilating arterioles surrounding the site of the vascular occlusion and inhibition of apoptosis (neuronal cell death) while also facilitating neuronal remodeling through the promotion of angiogenesis.

The Senior Director of Quality is responsible for the strategic development and execution of DiaMedica Therapeutics quality programs and is accountable for the execution and administration of the DiaMedica Therapeutics Quality Systems to support GCP, GMP, and GLP compliance in accordance with ICH, US and EU regulations. This position is a strategic part of our senior leadership team and is expected to build and lead the quality function across our organization on global quality matters. This position will also develop strong relationships with external consultants/contractors, as necessary to support QA activities and responsibilities. This position requires expertise in current Good Manufacturing Processes (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and relevant regulations. The successful candidate will drive, promote and embed a culture of ethics, integrity and continuous quality improvement that will focus on delivering efficiencies.

Major Responsibilities

• Build Quality Systems that 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 an effective Quality governance and continually improves governance to meet business and compliance needs.
• Ensures Quality and Compliance strategic direction and oversight for manufacturing, supply chain, nonclinical and clinical. Determines applicable quality standards and regulations and provides guidance and quality oversight to ensure ongoing compliance.
• Establishes strong working relationships with external manufacturers of our products and assures alignment of our Quality Systems and requirements with these CDMOs. Ensures products manufactured at CDMOs meet company quality standards and government regulations.
• Establishes, maintains, and has oversight of internal Quality Management Systems. Continually establish and improve quality systems, initiatives, priorities, and timelines.
• Ensure continual evolution and advancement of standards and requirements for client engagement processes, including operational oversight and continuous improvement for proactive quality management.
• Ensures appropriate quality criteria built into selection, implementation or upgrading of electronic systems used to support any GXP related activities
• Provide regulatory compliance and QA advice, guidance and support for internal stakeholders
• Provides appropriate Quality oversight of external vendors (CMOs, CROs, etc.)
• Provides leadership and mentorship of 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.
• Counsels, trains and interprets quality requirements to ensure we and our vendors maintain in a state of compliance.
• Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to our team.
• Perform due diligence
• Serves as an escalation point for corporate quality issues.
• Serves as 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.
• Design and conduct GCP, GLP and GMP training programs for staff

Qualification Requirements

• 15+ years of relevant experience in GXP, QA leadership positions in a Biotech or Pharmaceutical industry.
• Demonstrated a successful track record of developing strong relationships across a variety of stakeholders in pursuit of excellence
• Bachelor’s degree or higher in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered. Master’s Degree (preferred)
• 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 ICHQ9 principles and has demonstrated the ability to utilize Quality Risk Management principles in everyday practice.
• A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members
• Pro-active in identifying opportunities with a strong solution minded approach and flexibility to emerging challenges based on scope and growth of the organization.
• Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management
• Ability to prioritize competing activities and manage resources and budget accordingly
• Excellent interpersonal and communication skills (oral and written) with the ability to work independently and in a team environment
• Demonstrates good judgement and seeks the advice of others when necessary

Work Environment & Pay Transparency

This position resides within a normal office working environment with very little travel required.

The base salary range for this position is $137,000 - $225,000; the exact salary depends on several factors such as experience, skills, education, and budget. In addition to base salary, this position is eligible for participation in a highly competitive bonus program with possibility for overachievement based on performance and company results.  It is eligible to participate in our long-term incentive program.

DiaMedica offers a variety of benefits to eligible employees, including health insurance coverage, wellness and family support programs, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and vacation time, and many others. Many of these benefits are subsidized or fully paid for by the company.

EEOC Statement

DiaMedica Therapeutics Inc. believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.