Associate Director, Clinical Quality Assurance (Cambridge, MA, US, MA 02139)

Cambridge, US; Gaithersburg, US; New England, US; New Jersey, US   |   full time   |   Job ID: 10150

About the role:

As Associate Director, Clinical Quality Assurance Compliance, you’ll help ensure clinical trials meet Good Clinical Practice (GCP) requirements and protect patients’ safety, rights, and wellbeing. Your proactive, risk-based quality oversight supports BioNTech’s clinical development and contributes to our work developing innovative medicines.

You’ll partner with clinical trial teams, internal quality groups, and external vendors. Your work will span trial oversight, inspection readiness, audits, and continuous improvement, helping teams identify and address quality risks throughout clinical development.

Your contribution:

Set and oversee risk-based quality strategies for assigned clinical trials to support compliance and patient  protection

Advise trial teams on quality risks, deviations, investigations, root causes, corrective and preventive actions, and effectiveness checks

Maintain trial quality dashboards and coordinate inspection-readiness activities, including preparation of sites, records, narratives, and mock inspections

Support health authority inspections, audits, and follow-up activities, including back-room support and timely completion of corrective actions

Oversee quality aspects of clinical vendors, including quality agreements, partner compliance, and relevant quality metrics

Strengthen the organization’s quality culture by mentoring colleagues, improving processes, and contributing to clinical quality procedures

A good match:

University degree in life sciences, with 5–8 years of experience in a Good Clinical Practice-regulated environment, including 3–5 years in a Quality Assurance role

Knowledge of clinical trial quality oversight, risk management, investigations, corrective and preventive actions, and inspection readiness

Experience managing or supporting health authority inspections is preferred

Proactive, collaborative approach with sound judgment and a commitment to transparency and continuous improvement

Your benefits and remuneration:

If the position is filled in the US, the Expected Pay Range is $146.300/year to $234,100/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.  Compensation at other locations may vary significantly.

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.