Quality Assurance Manager / Senior Manager GMP/GDP
Regulatory | Waltham, MA | Full Time
Oncopeptides is a global biotech company committed to developing targeted therapies for patients facing hard-to-treat hematological diseases. Oncopeptides has one U.S. FDA approved product, PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen. PEPAXTO is approved for patients with triple-class refractory multiple myeloma and was evaluated in several clinical studies including the pivotal Phase 2 HORIZON study and is currently being evaluated in the confirmatory Phase 3 OCEAN study. Oncopeptides’ headquarters is in Stockholm, Sweden, with a U.S. headquarters in Boston, Massachusetts. In addition to Boston, Oncopeptides has a footprint in Los Altos, California, another U.S. biotech hub. PEPAXTO®is a trademark of Oncopeptides AB (publ).
The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.
The company is in a strong financial position and has an effective Executive Team and Board of Directors. Discover more about Oncopeptides at www.oncopeptides.com
The Quality Assurance Manager or Senior Manager GMP/GDP is responsible for ensuring adequate quality assurance activities within all GMP and GDP areas at Oncopeptides AB and Oncopeptides Inc. The expert role is mainly within Good Manufacturing Practice and Good Distribution Practice however the responsibility in the role includes coordination and support of all GXP activities within the company.
The Quality Assurance Manager or Senior Manager GMP/GDP is responsible for ensuring that the Oncopeptides Quality system complies with all applicable GMP and GDP regulations and requirements in Europe and US.
This position is based in Waltham, MA.
Key responsibilities include, but are not limited to:
Monitor local, regional and global GMP/GDP requirements and assess impact for the company
Monitor all requirements for the importation of medical products into the European Union and United States
Support internal and external Qualified Persons
Act as subject matter expert for GMP and GDP related topics
Execute batch release according to FDA regulations
Review and approve batch records
Develop and update procedures
Ensure that relevant customer complaints are managed effectively
Keep records of any delegated duties
Represent and support quality-related authority inspections
Conduct or oversee customer/client audits at Oncopeptides and at subcontracted partners, if required
Prepare, conduct and follow up physical audits of external manufacturing sites, warehouses and transporters according to regulatory requirements
Lead investigations related to suspected scientific misconduct and/or serious breach of GXP, analyze investigational findings to identify root causes in collaboration with related experts within the field
Manage and oversee corrective and preventive actions
Coordinate and oversee any recall operation for medical products
Assure reporting to relevant parties of potential or confirmed violations, as appropriate, in accordance with company standards
Execute the responsibilities according to lawful and ethical standards
Perform additional duties as requested by Oncopeptides
Bachelor’s degree in scientific or allied health field
5 years of relevant QA experience
Experience within manufacturing environment
Experience working with external vendors
In-depth knowledge of FDA regulations, EU regulations, GMP and GDP guidelines
Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers
Ability to work independently
Ability to travel for audits