Job Title: Senior Quality Assurance Manager - External Compliance
We are seeking a highly skilled and experienced Senior Quality Assurance Manager to join our team. The successful candidate will be responsible for ensuring the quality of external contract manufacturers and suppliers, while also serving as the Regulatory interface between Contract Manufacturing Operations, Quality, and internal Reg Affairs.
Job Description
The ideal candidate will have a Bachelor of Science Degree in a relevant field, such as Pharmacy or Engineering, and at least 5 years of experience in Pharmaceutical or Bio Quality Assurance roles with direct responsibility for product quality decisions.
Key Responsibilities:
* Manage all aspects related to product quality or compliance for a portfolio of external contract manufacturers and suppliers.
* Assess the quality of external supplier's products, processes, and related documents while ensuring product specifications are met and quality systems are maintained.
* Support internal and external partners with auditing activities related to external supply activities.
* Support Compliance Assessments to ensure current GMP/GDP adherence.
* Manage Risk at Vendors implementing Quality Improvement Plans and support Risk assessments.
* Support onboarding activities of new CMOs or product launches within the portfolio.
* Support offboarding activities for exiting CMOs/products/SKUs within the portfolio.
* Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles, prior work experience, and concepts in other technical areas.
Requirements:
* Bachelor of Science Degree in a relevant field.
* At least 5 years of experience in Pharmaceutical or Bio Quality Assurance roles with direct responsibility for product quality decisions.
* Advanced computer skills for MS Office and enterprise systems such SAP, QTS, Vault.
* Demonstrated personal leadership to work in virtual teams and cross-functional projects/initiatives.
* Demonstrated experience managing complex quality and compliance activities.
* Demonstrated knowledge of US, European, and global cGxPs, compliance issues, inspectional trends, industry quality assurance practices.
* Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the role.
Benefits
This is an excellent opportunity to work with a leading pharmaceutical company and contribute to the development of high-quality products. The successful candidate will have the opportunity to work independently, receive instructions primarily on unusual or complex problems, and provide Performance Metrics for key performance indicators.
Others
We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please apply now.