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About the Role
The Sr. Quality Engineer provides quality assurance support for biologic therapeutics, ensuring compliance with cGMP, ICH, and global regulations. This role supports projects impacting product quality, focusing on supplier relations, validation, quality culture, risk management, process improvement, CAPA, audits, and quality system enhancements.
Responsibilities
- Support supplier management, including qualification, audits, SCARs, and Quality Technical Agreements.
- Manage suppliers of materials, parts, and services using a risk-based approach.
- Perform and support internal and external audits.
- Collaborate with internal departments and external regulatory bodies on compliance.
- Review and approve Complaint, CAPA, Audit Findings, and Deviation investigations.
- Provide quality system support by improving processes and systems, and updating/creating site procedures.
- Participate in third-party audits (Notified Body, FDA).
- Support high-risk investigations to ensure effective resolutions and prevent recurrence.
- Guide, coach, and train personnel on auditing, Root Cause Analysis, CAPA, and deviations.
- Escalate Quality issues to management based on risk, trend, and compliance.
- Ensure site metrics comply with internal requirements and goals.
- Conform with all regulations, policies, work procedures, instructions, and safety rules.
- Contribute to continuous process improvement, efficiency, quality culture, and waste elimination.
- Provide excellent customer service to internal and external customers.
- Perform other duties as assigned.
Requirements
- Bachelor’s degree in science (chemistry, microbiology, or biotechnology preferred).
- Minimum 7 years of experience in GMP Quality roles.
- Minimum 3 years of experience in the pharmaceutical industry.
- Demonstrated experience in problem-solving, root cause analysis, and risk management.
- High proficiency in standard electronic business tools (Outlook, Word, PowerPoint, Excel).
- Effective communication of technical issues to various functional levels.
- Ability to make data-driven decisions.
- Passion for change and continuous improvement.
- Strong sense of urgency.
- Effective technical writing skills.
- Ability to understand quality requirements for supplier negotiations and quality agreements.
- Certified auditor preferred.
- Certified Quality Engineer preferred.
- Experience in computer system validation requirements is a plus.
- Experience in Veeva, SAP, and/or Trackwise is a plus.
Location
- Roseville, Minnesota
Work Type
- Full-time
Experience Level
- Senior
Education Level
- Bachelor's degree
Salary/Compensations
- $93,818 to $174,233
Benefits
- Competitive total compensation
- Flexible benefits
- Personal support
- Tailored learning and development opportunities
- Comprehensive healthcare (medical, dental, vision)
- 401k plan with company match
- Short-term and long-term disability coverage
- Basic life insurance
- Wellness benefits
- Reimbursement for certain tuition expenses
- Sick time (1 hour per 30 hours worked)
- Vacation time (accrues up to 120 hours in first four years, 160 hours in fifth year)
- 15 paid holidays per year
- Paid parental leave
About the Company
- Ferring is a privately-owned biopharmaceutical company focused on developing life-changing therapies.
- The company fosters an entrepreneurial spirit and a long-term perspective.
- Ferring has a 70-year history of commitment to science and research.
- Recognized as one of "The World's Most Innovative Companies" by Fast Company.
- Honored by Fortune on its "Change the World List".
- Ferring US is Great Places to Work® Certified.
Equal Opportunity
- Ferring is an equal opportunity employer.
- Employment decisions are based on merit, competence, performance, and business needs.
- No discrimination based on race, color, religion, marital status, age, national origin, ancestry, disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other protected status.
- Proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans).
- Maintains a drug-free workplace.