Manufacturing Compliance Lead

Gaithersburg, US | full time | Job ID: 8845

Primary responsibilities Include:

Generate, own, and provide subject matter expertise to Quality System records as minor/major deviations, CAPA and change control records.

Lead investigations for Quality deviations and incidents as required. Conducts Quality investigations with focus on performance improvement and risk reduction.

Perform walkthroughs of areas where deviation occurred and ensure thorough understanding of associated manufacturing processes.

Collect and evaluate documentation required to support investigation (i.e. logbooks, batch records, test results, etc.)

Develop a comprehensive understanding of the manufacturing processes and the associated risk management control strategy developed to identify process risks around the associate processing steps.

Organize and lead cross functional team meetings including initial and follow up meetings to ensure robust investigation conclusions, effective communication, and sharing of learnings.

Drive the identification and implementation of effective CAPAs to support reduction in reoccurrence and prevention.

Coordinate review of investigation with Team Leads, Area Managers, Site Quality Authority, Subject Matter Experts, etc., address review comments, obtain alignment and ensure approval and closure of the investigation.

Manage workload and ensure adherence to a 30-day investigation closure process, including escalation of roadblocks which could result in delays.

Ensures required management and Quality approvals on final investigations while satisfying established due dates.

Provide overview of investigations during regulatory inspections, internal audits and customer audits and respond to verbal and written inquiries.

Continuously monitors and trends deviation and CAPA performance and provides regular updates and recommendations to senior leadership.

Will be required to perform task of walking the process and understanding the areas in which the incidents occurred which may require periods of lifting (<50lbs), standing and gowning into cleanroom environments, such as, Grade D, Grade C, and Grade B.

Will be required to write investigational reports within the enterprise system which will require periods of sitting/typing.

What you have to offer

Requirements:

• Bachelor’s Degree in Life Sciences or Engineering with 3 years of experience in a GMP manufacturing environment, with a focus on CAPA’s, Change Controls, and Deviation Investigations.
• Strong understanding of regulatory requirements related to CAPA, change controls, and deviations.
• Experience leading cross-functional teams and driving process improvements.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Must possess a positive attitude and promote BioNTech’s Core Values.
• Ability to work on-site, daily. Off hours and weekends may be required based on workload and business needs.
  
  

Preferred Requirements:

• Previous cell therapy experience; pre-clinical, clinical, and/or commercial.
• Pro-active, result driven, and ability to prioritize work to meet deadlines.
• Ability to perform complex data analysis and effectively drive problem solving.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• A fact-based problem solver with strong troubleshooting and problem-solving skills.
  
  

Your Benefits

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. Salaried/Position-Targeted Hourly Employees working 30 hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to:

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance
  
  

…and more! More details to be shared.

Expected Pay Range: $100,000/year to $140,000/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.

Located in the BioHealth Capital Region near Washington DC and ranked among the top biopharma hubs in the country, Gaithersburg, Maryland offers a unique and diverse cluster across industry, government, and academia for top talent and scientific innovation. As a pivotal player within the life sciences community, Gaithersburg is distinguished by its robust infrastructure and strategic location near the nation’s capital. The city’s strategic significance is amplified by its state-of-the-art manufacturing facilities that cater to the rigorous demands of the life sciences industry; Gaithersburg’s manufacturing sector is defined by advanced technologies and complies with the most stringent regulatory standards, ensuring the production of high-quality pharmaceuticals, biologics, and medical devices. In the coming years, Gaithersburg will continue to be a vital contributor to the future of medical science and technology.

Apply now - We look forward to your application!

Apply for our Gaithersburg, US location and simply send us your documents using our online form.

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.