SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 470 employees in 16 countries and a group revenue in excess of €350m.
Our portfolio of 80+ rescue medicines makes a real difference in the lives of patients and their caregivers, giving every one of our employees a sense of purpose.
Our Purpose is supported by our 4 key values:
We make patients our priority
We act with integrity and accountability
We work together as one team
We look for better ways forward
Broad Function
The New Quality Team Officer will be part of an innovative Biotech-oriented organization that is a fast-paced company striving to supervise and support external service at the highest level and provide its employees with a platform to learn and grow.
This role involves working closely with contract manufacturing organizations (CMO) and contract testing laboratories (CTL). It also requires dealing with multiple products and multi-contractors sites that provide full-spectrum biopharmaceutical manufacturing services in the production of bulk Active Pharmaceutical Ingredient (DS) and Drug Product (DP).
Create and enhance collaborative and trusting relationships with external manufacturing sites and internal SMEs and establish effective communication.
Responsible for Quality Assurance oversight of the external manufacturing operations and related projects to ensure the corresponding GMP compliance in every phase according to regulatory expectations. This includes:
Provide guidance and support to external manufacturing with Product Disposition;
cGMP Document Review; involving reviewing both master and executed Batch Manufacturing Records, validation/qualification protocols and reports;
Coordination/support for batch release, supporting QPs in the batch certification process;
Arranging, attending, taking minutes from calls with CMOs/CTLs, and tracking actions;
Supervise and assess the changes that affect external manufacturing including but not limited to: facility, equipment, raw materials, and test methods;
Support, review and approve External Investigations and ensure issues are tracked within the company QMS system;
Ensure escalation of substantial issues to the Quality Assurance Manager;
Ensure External manufacturing risks are adequately addressed within site Risk Management Processes.
Education and Experience
Life science degree including Biology, Microbiology, Biochemistry, Pharmacy, Chemistry, or Biotechnology (or equivalent) is preferred.
Experience dealing directly with both regulatory agency personnel as well as the CDMO provider representatives is preferred.
GMP Knowledge (EU and FDA) with practical application.
Experience in operational GMP in a pharmaceutical manufacturing environment including batch disposition.
Experience in working in a multidisciplinary environment and supplier relation management is preferred.
At least 3 years of experience in Quality or Quality Assurance functions within the Pharmaceutical or Medical Device Industry is required.
Skills and Attributes
Understanding of the regulatory/Quality responsibilities for active pharmaceutical ingredient (DS) and drug product (DP) batch disposition.
Familiarity with several elements of pharmaceutical manufacturing.
Good written and oral English communication skills.
Ability to respond to common inquiries, regulatory agencies, or members of the business community.
High tolerance for ambiguity in a complex environment. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to build partnerships both internally and externally.
Ability to think and act independently.
Demonstrated negotiation and influencing skills.
Knowledge of MS Word, Excel, PowerPoint, and data management platforms.
Willing to travel within the UK, EU, and internationally for up to 15% of the time.
Strong written, verbal, and presentation skills.
SERB Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities, and a culture of working together in a supportive way built on our strong foundation of values.
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