Planet Pharma · 8 hours ago
Sr. Manager, GMP Quality
Marlborough, MA
Full-time
Onsite
Senior Level, Lead/Staff
$95/hr - $101/hr
8+ years expPlanet Pharma is a company focused on the pharmaceutical industry, seeking a Sr. Manager for GMP Quality. The role involves overseeing quality assurance processes, managing cross-functional project teams, and ensuring compliance with GMP standards in the manufacturing of drug products.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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 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 eQMS, 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
Qualification
Required
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 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 eQMS, 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
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 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
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
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase