Job Description
Job Title: Sr. Manager, GMP Quality
Location: Remote (Marlborough, MA)
Duration: 07 months on W2 contract
Job Description
The individual will support product lifecycle management activities, commercialization efforts for oncology programs, and expedited product disposition across commercial and clinical programs. This additional resource will help the team manage workload demands, maintain operational efficiency, and support key strategic initiatives.
Duties:
Location: Remote (Marlborough, MA)
Duration: 07 months on W2 contract
Job Description
The individual will support product lifecycle management activities, commercialization efforts for oncology programs, and expedited product disposition across commercial and clinical programs. This additional resource will help the team manage workload demands, maintain operational efficiency, and support key strategic initiatives.
Duties:
- Be the QA representative on cross-functional project teams. Responsible for communicating with the Quality and Production departments at domestic and international contract manufacturing organizations, and within SMPA's Quality, Supply Chain, CMC, and Commercial Manufacturing departments.
- Conducts product release activities for clinical and commercial drug substances and drug products; including review and approval of Master Batch Records, Executed Batch Records, release and stability testing documentation, and batch disposition. These activities must be conducted in a timely manner to ensure continued product supply while ensuring Quality and Safety of the product.
- Partners with CMC and Commercial Manufacturing to conduct technical transfers and validation of new or existing processes and products to domestic and international contract manufacturing organizations.
- Supports commercial validation activities by reviewing validation protocols and reports.
- Ensures compliance to existing procedures and supports continuous improvement opportunities by identifying areas where improvements and efficiencies can be gained through SOP and compliance standard revisions.
- Authors, reviews and approves standard procedures and electronic systems, as needed.
- Leads, authors, reviews and/or approves CMOs Quality Events, Investigations, CAPA, Change Controls, and Complaints, as well as initiating in SMPA's e QMS, as needed. This may require timely interface with domestic and international suppliers.
- Serves as Person-in-the-Plant, as needed.
- Authors relevant sections of Annual Product Reviews by compiling appropriate data and metrics and making appropriate recommendations.
- Other duties as assigned.
Skills:
- Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products.
- Experience with managing external CMOs, contract laboratories, and third-party logistics suppliers.
- Must have experience in reviewing and approving master and executed batch records and performing final disposition of drug substances and products.
- Experience managing quality events (investigations, CAPA and change control), and working knowledge of formal risk management tools and assessments. The individual must demonstrate the ability to evaluate and assess technically complex quality events, as well as the ability to document these events with excellent technical writing skills.
- Experience in evolving GMP related quality systems, policies, and procedures to ensure compliance with evolving standards as well as improving the efficiency of related workflows.
- Strong ability to analyze complex issues to develop relevant and realistic plans, programs, and recommendations.
- Excellent verbal and written communication skills, including ability to interact effectively with senior management, partners, and project core team members.
- Self-motivated, flexible, and able to prioritize work and handle multiple assignments in a fast-paced environment, while maintaining a high level of quality and compliance.
Education:
- Minimum of Bachelor's degree in a scientific discipline (e.g., biology, chemistry, engineering, pharmacy) or relevant field of study.
- 8+ years of experience required, with relevant experience in biotech or pharmaceutical industry with most experience in a Quality role.
Compensation:
The hourly rate for this position is between $100-105 per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits:
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com
Numbers & Facts
| Location | Marlborough, MA (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $100–$105 Per Hour |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
Skills
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- CMOSunmatched
- Change Controlunmatched
- Chemistryunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Contract Manufacturingunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cross-Functionalunmatched
- Data Collectionunmatched
- Documentationunmatched
- Dosage Formsunmatched
- Drug Productsunmatched
- Establish Prioritiesunmatched
- Event Managementunmatched
- GMP (Good Manufacturing Practices)unmatched
- Laboratoryunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Metricsunmatched
- Oncologyunmatched
- Operational Supportunmatched
- Pharmacyunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Product Lifecycle Managementunmatched
- Product Reviewsunmatched
- Product Safetyunmatched
- Product Supportunmatched
- Quality Assuranceunmatched
- Quality Managementunmatched
- Regulatory Complianceunmatched
- Risk Managementunmatched
- Safety/Work Safetyunmatched
- Standard Operating Procedures (SOP)unmatched
- State Laws and Regulationsunmatched
- Strategic Planningunmatched
- Supply Chainunmatched
- Team Lead/Managerunmatched
- Technical Analysisunmatched
- Technical Writingunmatched
- Third-Party Logistics (3PL)unmatched
- Time Managementunmatched
- Validation Planunmatched
- Writing Skillsunmatched
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