Senior Quality Engineer
Ferring Pharmaceuticals
Summary
The Sr. Quality Engineer works under minimal supervision to provide quality assurance support in accordance with regulatory requirements as it relates to biologic therapeutics and compliance with cGMP, relevant ICH and Global regulations. This role will support the execution of medium complexity projects that will impact the Quality of the product significantly throughout the implementation of changes involving supplier related items, validation process, Quality Culture, risk management, process improvement, CAPA, internal audits and quality system improvements.
Job description
Responsibilities
- Support supplier management process which may include supplier qualification, audits, SCARs, reviewing and providing input to Quality Technical Agreements and on-going supplier monitoring.
- Manage suppliers of materials, parts, and services through a risk-based approach.
- Perform and support internal and external audits.
- Interface and collaborate with internal departments and external regulatory bodies regarding compliance needs as required.
- Support review and approve Complaint, CAPA, Audit Findings, Deviation investigations to provide guidance to ensure effective investigations are completed.
- Provide continued quality system support by improving processes and systems and by updating and creating site procedures.
- Participate in third party (Notified Body, FDA) audits as required.
- Supports high-risk investigations to document Quality Issues resolutions within a CAPA, SCAR, Deviation, Audit finding to ensure proper and robust actions are taken to eliminate re-occurrence.
- May guide, coach, and train other personnel on topics such as auditing, Root Cause Analysis, CAPA, deviations, etc.
- Escalate Quality issues to upper management based on risk, trend, and compliance assessment.
- Ensure Site Metrics are complying with internal requirements and goals established.
- Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
- Contributes to continuous process improvement efforts, improve efficiency, quality culture reinforcement, and eliminate waste.
- Provides a "Customer Service" attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
- Performs other duties as assigned based on business needs.
Requirements
- Bachelor's degree in science (chemistry, microbiology or biotechnology) with microbiology preferred.
- Minimum 7 years' experience in GMP Quality roles.
- Minimum 3 years' experience in pharmaceutical industry.
- Demonstrated experience in problem solving, root cause analysis and risk management methods.
- High proficiency in use of standard electronic business tools: Outlook, Word, PowerPoint, and Excel.
- Effective communication skills of technical issues to various functional levels, ability to make data driven decisions, passionate for change and continuous improvement, and embodying a strong sense of urgency.
- Effective technical writing skills and ability to understand quality requirements as they relate to 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.
Requirements
- Bachelor's degree in science (chemistry, microbiology or biotechnology), microbiology preferred
- Minimum 7 years' experience in GMP Quality roles
- Minimum 3 years' experience in pharmaceutical industry
- Demonstrated experience in problem solving, root cause analysis and risk management methods
- High proficiency in Outlook, Word, PowerPoint, and Excel
- Effective communication skills of technical issues to various functional levels
- Ability to make data driven decisions
- Effective technical writing skills
- Ability to understand quality requirements as they relate to 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
Benefits
- Medical, Dental & Vision
- 401(k) Plan
- Company 401(k) Match
- Short-Term Disability
- Long-Term Disability
- Basic Life Insurance
- Wellness Benefits
- Tuition Reimbursement
- Sick Time
- Vacation Time
- 15 Paid Holidays
- Paid Parental Leave
- Annual Bonus
- Flexible Benefits
- Learning & Development
Company overview
Ferring Pharmaceuticals is a Swiss multinational biopharmaceutical company specializing in reproductive health, maternal health, gastroenterology, and urology. Founded in 1950 by Dr. Frederik Paulsen Sr. and Dr. Eva Paulsen in Malmö, Sweden, the company has grown into a global leader with headquarters in Saint-Prex, Switzerland. Ferring employs over 7,000 people worldwide and operates in more than 50 countries, marketing its products in over 100 countries. The company is privately owned and research-driven, with a strong commitment to building families and helping people live better lives. Ferring has been developing treatments for mothers and babies for over 50 years and is at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. The company's portfolio includes leading products such as Menopur for reproductive medicine, Pentasa for gastroenterology, and Adstiladrin for bladder cancer treatment. With manufacturing facilities across Europe, South America, China, India, and the United States, Ferring maintains a robust global presence while maintaining its focus on specialty biopharmaceuticals that address significant unmet medical needs.