The QA Manager/Senior Manager is responsible for providing quality oversight for clinical and commercial GMP activities at contract service providers (CSPs) including analytical method validation and transfer protocol/report review, stability protocol/report review, data review, deviation, change control and CAPA review and approval. The successful candidate must have a strong GMP background and small molecule expertise. He/she will support analytical activities for Active Pharmaceutical Ingredient (API) and Drug Product by working cross functionally with Analytical Chemistry, Formulation and Contract Manufacturing groups within Myovant and with personnel at CSPs.
The individual will assist in the development and continual improvement of GMP quality systems at Myovant in compliance with appropriate regulations, guidelines and procedures. He/she must have the ability to work independently and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job.
Essential Duties & Responsibilities
- Serve as lead for assigned projects within the QA function. Manage QA activities related to review and approval of analytical methods, method validation, method transfer and stability protocols for API and Drug Product for use in clinical stage and commercial testing.
- Perform quality review of test results generated for commercial QC testing at CSPs.
- Provide oversight of internal and external quality records including deviations and CAPAs. Assure thorough and compliant investigations are performed with identification of appropriate corrective actions.
- Proactively work with cross functional teams to ensure timely closure of quality records (Deviations, CAPAs, Change Controls, Complaints, etc.).
- Collaborate with CSPs to address quality issues.
- Provide oversight of commercial stability program.
- Prepare and report quality metrics to evaluate the performance of CSPs.
- Collaborate with QA team members to support QMS system design and enhancement.
- Author and/or revise SOPs, as needed.
- Serve as a QA representative, participate on cross-functional teams and perform other duties as assigned or required.
- May support Health Authority inspections and CSP audits, if requested.
- Identify, design and implement continuous improvement opportunities.
Core Competencies, Knowledge and Skill Requirements
- Strong small molecule and analytical background with an in-depth knowledge of regulatory requirements for analytical method validation and transfer through all phases of development and commercialization.
- Strong knowledge of FDA and EU guidelines, GMP regulations, QA principles, industry practices and standards.
- Commercial QC experience, including stability program management.
- Prior experience providing quality oversight of CSPs.
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment, integrity, and trust building behavior.
- Must have excellent customer-service orientation, high degree of professionalism, ability to work with limited direction and work successfully within a cross-functional team/partnership environment.
- Demonstrates a positive, ‘can do’ and solution-oriented attitude.
- Ability to learn and utilize computerized systems for daily performance of tasks.
- Strong PC experience and proficiency in MS Office (Outlook, Word, Excel, PowerPoint, SharePoint a plus).
- Good organizational skills, attention to detail and solution focused.
- Ability to prioritize and handle multiple projects simultaneously.
Communication & Interpersonal Skills
- Excellent written and verbal communication skills, detail-oriented with a commitment to accuracy.
- Ability to build trust and respect within the organization.
- Ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly growing dynamic company.
- Interacts with other Myovant employees, and as required, with external representatives from across the supply chain for Myovant product.
- Bachelor’s degree in scientific discipline or related field.
- 8+ years of progressive global quality background with hands-on experience in quality systems and quality assurance or quality control is preferred.
- Strong knowledge of Good Manufacturing Practices (GMPs), Quality System standards and global regulatory requirements.
- Demonstrates a full working knowledge of compliance requirements.
- ASQ (American Society for Quality) certification(s) a plus.
TRAVEL, PHYSICAL DEMANDS AND WORK ENVIRONMENT
- Regularly required to operate standard office equipment
- Ability to work on a computer for extended periods of time
- Regularly required to sit for long periods of time, and occasionally stand and walk
- Regularly required to use hands to operate computer and other office equipment
- Occasionally required to stoop, kneel, climb and lift up to 20 pounds
If you require any accommodations, please email email@example.com.
Equal Employment Opportunity