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Alder Biopharmaceuticals, Inc.
Manager, QA - Vendor and Regulatory
Alder is revolutionizing the way antibody therapies are identified, selected, developed and produced. Our proprietary technologies make great strides possible in the field of antibody therapeutics, yielding innovative potential new treatments for conditions such as migraine and rheumatoid arthritis.
This position is responsible for the ongoing development, execution and oversight of the Quality Audit, Regulatory Compliance, Supplier Qualification and Vendor Management Quality Systems at Alder Biopharmaceuticals. This role will lead the quality compliance team in the continued development of Supplier Qualification and Audit quality systems, and Inspection Readiness activities to support commercialization readiness. The position will be filled at a level commensurate with experience.
Specific responsibilities will include:
- Responsible for Quality oversight of the Supplier Quality Management (SQM) function for Alder GxP vendors and suppliers.
- Responsible for the internal audit function to ensure compliance with all applicable regulatory requirements, company procedures and industry standards.
- As needed, author/review vendor audit reports and ensure effective CAPAs are identified and implemented.
- Manage the implementation/revision of quality agreements and standardize quality system targets with vendors.
- Regulatory Filing support.
- Assemble primary documents to support regulatory filings.
- Coordinate reviews of regulatory submissions working with site Subject Matter and Technical Experts to assure timeliness, data integrity and accuracy.
- Coordinate responses to CMC questions regarding regulatory submissions.
- Inspection Readiness Program.
- Responsible for management and conduct of Inspection Readiness activities such as mock audits, gap assessments, position paper development and Inspection training.
- Working with cross functional teams, responsible for the process development and management of inspections.
- Management of direct report(s).
- Develop, track, trend and report Quality System metrics to ensure continuous quality improvements. Assist in the development and implementation of Quality Management Review.
- Collaborate with multiple vendors and Alder internal departments: Pharmaceutical Operations, Manufacturing, Manufacturing Logistics, Quality Control, Regulatory, and Clinical functions.
- Identify and Implement SOP and Quality systems development, maintenance, and improvement in areas of primary responsibility.
- Provide compliance guidance in the development of SOPs and systems for GMP functional areas.
- Support Validation and Compliance activities associated with commercialization.
- Other duties as assigned.
- BS or BA Degree in Life Science.
- At least 10 years in Pharmaceutical/Biotech Quality Assurance and at least 3 years of supervisory experience.
- Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices for biologics and parenteral applications.
- Strong background in auditing and vendor management and direct experience with regulatory filings and inspections.
- The successful candidate will have excellent written and oral communication skills, a flexible attitude with respect to work assignments, and the ability to proactively handle multiple tasks simultaneously.
- Strong computer skills, particularly with Microsoft Office Suite and Adobe Acrobat.
- Must possess skills and confidence to be able to effectively communicate internally and with personnel at multiple vendors.
- Potential for travel to vendor locations, including international travel.
Interested candidates should apply at: https://goo.gl/YRs3iQ
Alder Biopharmaceuticals, Inc.
Alder Biopharmaceuticals, Inc. is an Equal Opportunity Employer