Sr Manager- QC Validation Transfer and Registration for Biochemistry
About The Position
This position is on site at our Research Triangle Park, NC facility, and would include 20-30% travel, domestic and internationally About This Role The Senior Manager reports to the Global VTR Leader and is responsible for leading the VTR Biochemistry team at our biologics site, focusing on strategy, operations, and cross-functional alignment, overseeing analytical method development, optimization, validation, transfer, registration, investigation, and lifecycle management for late stage clinical and commercial products at internal/external sites and contract labs. The Senior Manager will prepare and review regulatory filings and respond to health agency requests (RtQs) using a risk-based approach. The senior manager also manages project prioritization, timelines, resources, and budgets and ensures compliance with global analytical strategies, CAPA, change control, deviations, and quality standards (GMP). The senior manager approves reports, analyzes data, and establishes new or alternative analytical methods.
Requirements
- Bachelor's degree, Master's or PhD preferred in molecular biology, cell biology, virology, biochemistry, or related field
- Minimum 10 years of experience in cGMP biotech/pharmaceutical industry within quality
- Expertise in large molecule (biologics)
- Possesses in-depth knowledge of GMP and pharmaceutical industry regulations and requirements, including but not limited to, FDA, EMA, ICH, USP, EP, JP, and CHP
- Extensive knowledge of analytical method validations and method transfers
- Ability to manage and support multiple complex activities simultaneously
- Demonstrated strong critical thinking and problem-solving skills
- Strong verbal and written communication skills with the ability to effectively communicate with all levels of management, internally and externally
- Leads and mentors a diverse team, promoting professional growth and development
- Proven experience in leadership role with a strong track record of team management
- Experience in conflict resolution and performance management
Responsibilities
- Define strategy, review regulatory filings, respond to agency inquiries, mitigate risks, and manage global change controls.
- Support audits and inspections
- Develop solutions for technical and compliance challenges; apply best practices to improve processes and services
- Lead and mentor a diverse team of scientists
- Provide technical and compliance support; resolve issues to maintain business and manufacturing schedules
- Build a high-performing team; Set clear goals, conduct reviews, and provide feedback
- Oversee complex projects, approve technical documents, and coordinate with QA, Regulatory, Validation, and other QC teams
- Act as interim VTR Biologics leader when needed
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
