Quality Assurance Manager, GCP

Princeton, New Jersey (US)
Competitive salary and benefits
May 28, 2018
Jul 28, 2018
Full Time

Quality Assurance Manager, GCP

Genmab is looking for an experienced and dedicated QA Manager to be a part of our QA GCP team. This position is based in our Princeton, NJ office.

Key Accountabilities

Reporting to the Senior Director, QA, the QA Manager will collaborate with colleagues across the organization, with the overall goal to develop new and innovative medicine for patients. The key responsibilities include but are not limited to:

• Gaining and maintaining expert knowledge in regulatory requirements and ICH GCP principles and ensuring that the information is implemented accordingly

• Preparing individual audit plans and audit/risk mitigation plans for larger projects/programs as needed

• Clearly communicating and reporting (verbally and in writing) audit outcomes to the rest of organization, and escalating quality issues as required

• Planning and leading audit activities at clinical site audits, sponsor audits, key document audits and system validation audits

• Participating in developing, maintaining and improving the Pharmaceutical Quality System within the GCP area

• Providing QA expertise to the organization and quality oversight of drug safety and pharmacovigilance functions

• Proactively assisting the organization in preparation, coordination, hosting, conducting, documentation and follow up for regulatory inspections

• Providing advice internally and externally on GCP, pharmacovigilance and clinical quality matters

• Reviewing and evaluating the quality of contract partners (i.e., CROs)

Skills & Experience

Master’s Degree in Life Science (Pharmacist, Human Biologist, Biochemistry etc.)

8 years of relevant QA experience within the pharmaceutical industry, including hands on experience in the pharmacovigilance area, conducting clinical trials, oversight of pharmacovigilance area and practical experience in regulatory inspection preparation and conduct

Experienced Auditors within the GCP area preferred

Strong understanding of Quality processes with flair for the practical angle to creatively reach a compliant solution

Collaborative and strategic minded

Customer focused and able to deal with ambiguity

Exceptional verbal and written communication skills

Proficiency in Word, Excel, and PowerPoint

Ability to identify and communicate Risk Tools flawlessly

Ability to see QA teammates as a valuable resource and desire to further build on the team to maintain effective working relationships throughout the GCP area in Genmab

Ability to prioritize, maintain a positive attitude and thrive in a fast paced and changing environment

Ability to travel (approximately 5 days per month)

Result and goal-oriented and committed to contributing to the overall success of Genmab

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