Quality Assurance Compliance Senior Manager
Alder BioPharmaceuticals, Inc., is seeking a Senior Manager, Quality Systems, whose primary responsibilities will be the development, implementation and maintenance of commercial quality assurance systems and the inspection readiness program at Alder BioPharmaceuticals and its contract vendors. This role will report directly to the Senior Director, QA Compliance.
Specific responsibilities will include:
- Support the design and implementation of a robust and compliant framework of GMP policies, procedures and processes.
- Serving as an internal customer champion, make recommendations to cross functional teams to continuously improve the quality systems which support commercialization.
- Lead the implementation of the pre-approval (PAI) Readiness program to facilitate the successful Alder PAI and liaise with contract vendors to provide Alder oversight and support of contract vendor PAI inspections.
- Track identified PAI gaps to closure both at Alder and at contract vendor locations.
- Prepare subject matter experts to present strategic position on Alder systems, reports and data during Alder and contract vendor PAIs.
- Oversee Consultants providing gap remediation and PAI preparation support.
- Support the activities related to BLA submission, IND and other regulatory filings as applicable.
- In partnership with QA Operations, implement Product Complaint, Annual Product Review and Recall Program to support Product commercialization.
- Act as a subject matter expert for the Product Complaint, Annual Product Review, and Recall Quality Systems during audits and regulatory inspections.
- Develop, track, trend and report Quality System metrics to ensure continuous quality improvements. Assist in the development and implementation of Quality Management Review.
- Provide mentoring and guidance to GxP personnel to build a strong quality driven culture
- Collaborate with multiple CMOs, Technical Operations, Manufacturing, Manufacturing Logistics, Quality Control, Regulatory, and Medical functions.
- Assist in the development of the GXP training program.
- Contribute to the definition of requirements, selection criteria and implementation of electronic Quality Systems.
- Perform Compliance review of protocols, reports, and data as needed. Support Compliance review of Regulatory Submissions.
- Support Validation and Compliance activities associated with commercialization.
- Other duties as assigned.
- BS or BA Degree in Life Science or related field.
- 8+ years of related experience in biotechnology/pharmaceutical Quality Assurance, including some prior supervisory responsibilities.
- Excellent working knowledge of cGMP requirements, FDA and ICH guidelines and industry best practices for biologics and parenteral applications.
- In-depth knowledge of quality systems and how quality systems are designed and operated to satisfy regulatory requirements in commercial GMP operations.
- Demonstrated understanding of regulated biotechnology processing.
- Ability to couple technical process understanding with a strong regulatory and compliance understanding to ensure that operations are conducted in an efficient, and compliant manner to deliver safe and effective therapies to our patients.
- Strong analytical and problem-solving skills.
- Demonstrated ability to work cross-functionally and to develop and maintain strong partner relationships both, internal and with external vendors.
- Demonstrated ability to influence teams and to balance scientific judgment and compliance to cGMP when a risk based approach is appropriate.
- 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 CMOs (Vendor management experience preferred).
- Potential for travel to CMOs, including international travel.