Senior Supplier Quality Assurance Manager
72% Flex
Offer summary
Qualifications:
Bachelors degree in technical/scientific field., Minimum 10 years in GMP, 7 years quality assurance., Comprehensive knowledge of GMP regulations., Understanding of manufacturing processes and analytical testing., Strong investigative capabilities and CAPA management..Key responsabilities:
- Oversee supplier quality system processes and validations.
- Manage change control systems for suppliers and products.
- Lead reviews, investigations, and risk assessments.
- Author and revise quality documentation, SOPs.
- Participate in quality audits & drive improvements.
Job description
Your missions
Responsibilities:
- Manage systems and processes to oversee supplier quality, including handling the supplier change control system, supplier investigations, and supplier validation activities.
- Oversee combination product development projects, ensuring compliance with quality standards and regulations.
- Manage and oversee the change control system, including initiating and processing change controls for both internal and external modifications affecting materials, systems, and documentation.
- Facilitate reviews and meetings for change control, tracking the implementation and closure of action items.
- Support quality assurance operations by reviewing production records, testing documentation, and overseeing lot disposition activities to ensure compliance with quality agreements and GMP standards.
- Conduct investigations into supplier and internal deviations, performing root cause analyses and developing corrective and preventive actions (CAPAs).
- Serve as a lead on quality assurance for combination product projects, including managing risk assessments and maintaining design history files.
- Author, review, and revise standard operating procedures (SOPs) and ensure all quality documentation complies with GMP, regulatory requirements, and corporate standards.
- Assist in audit preparations and follow-ups, both internal and external, to maintain compliance standards.
- Participate in and drive quality system improvements.
Qualifications:
- Bachelors degree or higher in a technical or scientific discipline.
- Minimum of 10 years' experience in a GMP-related field, with at least 7 years in quality assurance within the pharmaceutical or medical device industry.
- Comprehensive knowledge of GMP requirements and regulatory standards including 21 CFR Parts 4, 210, 211, and 820.
- Demonstrated understanding of manufacturing processes, technological transfers, and analytical testing in pharmaceutical and medical device contexts.
- Strong capabilities in conducting detailed investigations, including root cause analysis and CAPA management.
Preferred Qualifications:
- Experience with pharmaceuticals and medical devices strongly preferred.
- Proficient in quality system regulations across multiple standards and guidances, such as ICH guidelines.
- Exceptional communication and interpersonal skills to effectively interact at all organizational levels.
- Proven ability to manage multiple priorities and timelines in a dynamic, fast-paced environment.
- Strong organizational skills with an emphasis on detail and a commitment to high-quality work.
Required profile
Experience
Level of experience:Expert & Leadership (>10 years)
Industry :
Spoken language(s):
Check out the description to know which languages are mandatory.
Hard Skills
Soft Skills
- Effective communicator at all levels.
- Manage multiple priorities effectively.
- Detail-oriented; committed to quality work.
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