Job Description
The Fountain Group is currently seeking a Sr. Manager, GMP Quality for a prominent client of ours. This position is located remotely. Details for the position are as follows:
Job Title: Sr. Manager, GMP Quality
Location: Remote
Pay Rate: $105.26/hr
Duration: 7 Months
Job Description
- Serve as the QA representative on cross-functional CMC, Quality, Supply Chain, and Commercial Manufacturing project teams.
- Manage quality activities with domestic and international Contract Manufacturing Organizations (CMOs), contract laboratories, and third-party logistics suppliers.
- Conduct product release activities for clinical and commercial drug substances and drug products.
- Review and approve Master Batch Records (MBRs), Executed Batch Records (EBRs), release and stability documentation, and perform final batch disposition.
- Support technical transfers and process/product validation activities at CMOs.
- Review commercial validation protocols and reports for GMP compliance.
- Author, review, and approve SOPs, quality procedures, and electronic quality systems.
- Lead and manage Quality Events, Investigations, CAPAs, Change Controls, and Complaints within eQMS.
- Apply formal quality risk management tools to assess complex quality events.
- Support continuous improvement of GMP quality systems, procedures, and workflows.
- Serve as Person-in-the-Plant (PIP) at manufacturing sites as required.
- Prepare relevant sections of Annual Product Reviews (APRs) using quality data and metrics.
Education
- Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences, Engineering, or a related scientific discipline.
Required Skills
- GMP/GxP pharmaceutical manufacturing
- Pharmaceutical dosage forms and/or combination products
- Clinical and commercial product release
- Master Batch Records (MBR) and Executed Batch Records (EBR)
- Batch disposition
- Drug substance and drug product quality
- Contract Manufacturing Organizations (CMOs)
- Contract laboratories and third-party logistics suppliers
- Quality Events and Investigations
- CAPA and Change Controls
- Complaints management
- Formal Quality Risk Management
- eQMS
- SOP authoring, review, and approval
- GMP quality systems and compliance
- Validation protocols and reports
- Technical transfer
- Process and product validation
- Stability documentation
- Annual Product Reviews (APR/PQR)
Preferred Skills
- Experience supporting domestic and international CMOs
- Person-in-the-Plant (PIP) experience
- Experience with clinical and commercial manufacturing environments
- Experience improving GMP quality systems, SOPs, and compliance workflows
- Experience evaluating technically complex pharmaceutical quality events
- Experience with pharmaceutical quality metrics and trend analysis
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Numbers & Facts
| Location | Marlborough, MA (Remote) |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Skills
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- CMOSunmatched
- Change Controlunmatched
- Chemistryunmatched
- Continuous Improvementunmatched
- Contract Manufacturingunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Documentationunmatched
- Dosage Formsunmatched
- Drug Manufacturingunmatched
- Drug Productsunmatched
- Event Managementunmatched
- GMP (Good Manufacturing Practices)unmatched
- GxPunmatched
- Laboratoryunmatched
- Manufacturingunmatched
- Medical Productsunmatched
- Pharmaceutical Analysisunmatched
- Pharmacyunmatched
- Process Validationunmatched
- Product Reviewsunmatched
- Product Testingunmatched
- Quality Assuranceunmatched
- Quality Managementunmatched
- Quality Metricsunmatched
- Risk Managementunmatched
- Standard Operating Procedures (SOP)unmatched
- Supply Chainunmatched
- Technical Analysisunmatched
- Technical Supportunmatched
- Third-Party Logistics (3PL)unmatched
- Trend Analysisunmatched
- Validation Planunmatched
- Writing Skillsunmatched
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