Inozyme Pharma is a biotechnology company committed to developing novel medicines for the treatment of rare metabolic diseases characterized by mineral imbalances. We are singularly focused on developing new therapies for patients with devastating rare diseases. The company was founded in 2016 with technology licensed from Yale University and is well financed by a premier syndicate of venture investors. Inozyme Pharma is led by an experienced management team with a proven track record in rare disease drug development, regulatory approvals, manufacturing and operations.
Our employees are central to our ability to achieve our goals of helping patients. We’re looking for people to join our team who are collaborative, compassionate, resilient, and passionate about what we do.
Inozyme is looking to expand their Quality team with an experienced Clinical Quality professional providing leadership, compliance guidance and direction for introduction of investigation products (IP) to early phase clinical trials. The role will entail building out and establishing systems for clinical quality in a start-up/early phase, fast paced, growing organization. The incumbent will provide consultation in the interpretation of good clinical practice (GCP) regulations, guidelines, policies, and procedures. They will review and advise on the content of protocols, pharmacy manuals, investigators brochures, informed consent, etc. The new Clinical Quality Director must have the ability to align, direct and weigh in on clinical quality issues and lead investigations, review and comment on regulatory documents and can author policy and procedure. The clinical quality role will plan, conduct, and report on independent audits of internal systems/ procedures and vendors. This person shall support, maintain, and review QA systems, clinical training curriculum, and corrective action and preventative actions (CAPAs). This person should have recognized subject matter expertise in one or more of the following Quality Assurance areas: Clinical (GCP) compliance, biopharmaceuticals manufacturing, and/or regulatory affairs.
The Clinical Quality Director will report to the Vice President Quality and Compliance will lead and direct or may perform activities such as but not limited to development of and tracking of quality metrics, will lead real‐time quality oversight of the assigned clinical trials and the reporting thereof. The individual will also play a leadership role within the quality team as well as be the quality representive to the clinical operations and medical affairs group. This role will aid to ensure conformance with international domestic and internal quality system standards including but not limited to 21 CFR part 210, 211, parts 600’s, 11 and 312, EMA, GCPs, USP, EUPh., and ICH E6.
This individual will also provide solid technical and organizational leadership to Quality programs and activities and provide leadership and value-added services to the company. They will partner cross functionally to deliver the highest quality services to internal and external teams. The incumbent must be an outgoing, strategic thinker, excellent communicator and possess the ability to inspire and lead others to achieve the critical mission of this vital functional area.
Education and Qualifications:
- Minimally a Bachelor’s Degree in Life Sciences or equivalent experience. 7+ years of experience in a GCP environment or a combination of graduate level degree and work experience.
- 5+ Years prior management experience of 2-5 direct reports preferred
- Proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., eTMF, Quality Management System (QMS) software, such as MasterControl), including software programs generating reports and statistics. Ability to create, use and interpret scientific tables, charts, and graphs
Desired Skills & Experience:
- Extensive knowledge of FDA/EMA regulatory requirements applicable to Good Clinical Practice, clinical trial quality management for biologics
- Strong ability to communicate effectively to peers and all levels of the organization within and outside of department, and with external contacts
- Excellent organizational skills and analytical and problem solving abilities, strong verbal and writing skills and good interpersonal and leadership skills
- Possesses exceptional time management and multi-tasking abilities in order to meet commitments and deadlines
- Identifies potential compliance issues and opportunities for improvement
- Implement process improvements to enhance compliance and improve manufacturing process
- Team player with the ability to work collaboratively with other functions gaining their cooperation in dealing with issues of compliance
- Rational persuasion particularly in discussion with and between product development/IP production, medical affairs and Clinical Operations departments
- Critical thinking with the ability to read, analyze and interpret technical data
- Deductive reasoning with the ability to deal with abstract and concrete variables in situations where only limited standardization exists
- Demonstrated ability to make key decisions
- Technical knowledge of clinical trials, clinical trial management, and oversight
- Ability to lead, motivate and educate others on phase appropriate product quality processes and clinical quality aspects
- Capable of building effective relationships with internal and external stakeholders
- Able to operate in a dynamic, fast-growing biotech company with challenging timelines
- Able to travel as necessary up to 20% for potential audits
- Able to be in an office setting locally, for 3-5 days per week
Essential Duties and Responsibilities:
- Leads and manages the review and approval for supplier/vendor oversight with regard to CRO and CTLs
- Review of SOPs, investigations, corrective actions, change controls, and regulatory commitments in order to ensure compliance with quality standards and production schedules
- Performs or assists in CRO and clinical site audits to an audit plan or program
- Must possess in depth knowledge of essential documents and data in an eTMF system with demonstrated familiarity and some data audit capabilities
- Collaborate in SOP writing and/or review
- Leads the quality oversight for assigned global clinical trials (phase 1-3) in close collaboration with the clinical study team
- Will recruit, attract, hire and develop employees within the a clinical quality group. Mentors, coach, and provides feedback for growth. Oversees the Performance Management process and takes necessary disciplinary actions
- Ensures awareness and compliance with GCP, ICH and ROW regulatory authority regulations and requirements
- Defines deliverables for projects and efficiently utilizes resources in order to meet project goals and scheduled timelines
- Ensures short term and long term strategies are in place for department success
- Reviews and approves departmental procedures, protocols and reports
- Produces in close collaboration with clinical study team GCP quality metrics allowing real‐time quality monitoring and reporting; conducts trend analyses of GCP quality system metrics (e.g. audit observations, protocol deviations, CAPAs, GCP QA activities) for quality management reporting
- Plays a leading role in the continued growth of the quality and clinical quality team alongside the Vice President of Quality and Compliance, including quality strategy, infrastructure, vendor selection / management, team mentoring, and recruitment