Over the coming years, biotech will fundamentally rewrite the way we live. Gene editing and cell therapy are dramatically changing how we treat cancer and other major illnesses. Biofuels and biomaterials are transforming the cars we drive, the clothes we wear, and the makeup of everyday objects. Crop science and synthetic biology are producing sustainable and ethical food. Benchlings mission is to accelerate the research that propels us towards this reality, and magnify its impact, through modern software.
Every day, scientists around the world use Benchlings applications, platform, & analytics in their efforts to solve humanitys most pressing problems. For these scientists, Benchling is the central technology they use to conduct their research. Our customers include pharmaceutical giants, leading biotechs, and the worlds most renowned research institutes.
Benchling is hiring a GxP Compliance Manager to support our expansion into the development and manufacturing areas.
We are looking for a candidate who is has an in depth understanding of the GxP regulatory landscape as it relates to lab processes and systems.
In this role, you will you will focus on regulatory assessments, risk and audit areas. You will work to build audit readiness capability across the organization and will be responsible for preparing, organizing, and supporting audits as well as sharing best practices and lessons learned following audits. You will work closely with Benchlings product managers to document and maintain product regulatory assessments (Part 11, Annex 11, Data Integrity, GLP, GCLP, GMP etc.).
The right candidate will demonstrate excellent communication skills and will be comfortable explaining Benchlings compliance posture to both internal and external customers.
WHAT YOU WILL WORK ON
- Establishing and maintaining a comprehensive GxP audit and inspection readiness program
- Planning, scheduling and co-hosting customer audits including finalizing scope and agenda, compiling audit deliverables, and audit responses/ reports
- Evaluating the GxP compliance status of our offerings in relationship to relevant industry and regulatory agency expectations and assessing the effectiveness of established programs, systems and processes.
- Proactively identifying GxP compliance issues / risks that may affect product or established processes through well documented assessments and internal audits
- Providing guidance and training to internal teams on maintaining and continuously improving alignment with GxP regulatory requirements and other relevant regulatory standards
- Monitoring GxP intelligence (health authorities, industry trade organizations, etc.) to identify compliance trends and incorporate them into ongoing audit/inspection readiness plans
WHO YOU ARE
- Have 9+ years of experience working with GxP audits, risk and QMS. Life Sciences industry experience
- Have strong knowledge of lab systems and processes (LIMS, LES, EBR etc.) along with a solid understanding of regulatory requirements including FDA, EMEA, ICH, PIC/S etc. particularly as it applies to regulated software development
- The successful candidate will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
- Influencing skills in areas with no direct reporting authority
- Familiarity with SaaS business model and agile software development methodology
- Excellent written and verbal communication and presentation skills
- Ability to hustle, juggle multiple priorities, and get stuff done
- Excellent collaborator with strong sense of personal and professional integrity
Benchling welcomes everyone. We believe every member of our team enriches our diversity and inclusion by broadening our ways of problem-solving for future challenges. Even if you don't meet 100% of the qualifications for this job, we strongly encourage you to apply.
- Admit mistakes and shortcomings
- Deliver results
- Disagree and commit
- Obsess over customers
- Rely on work ethic
- Show empathy
- Recruit and develop the best
- Sweat the details
- Think and communicate clearly
- Unite around the mission
PERKS AND BENEFITS
- Work with a talented yet humble team
- Competitive compensation & equity package
- Weekly virtual social events, and annual company retreats
- 401k, Medical, dental, and vision insurance (US Employees Only)
- Monthly health & wellness stipend
- Yearly educational stipend
- Flexible & Generous Vacation Policy: If you feel you need a break, you can talk directly with your manager to find coverage and support while you are out of the office. Need time off to vote? We've got you covered.
- Quarterly company-wide mental health days off
- Holiday Shut-down: company-wide holiday shut-down between Christmas Eve and New Years
- Major US and EMEA holidays observed
- To support remote work conditions during the COVID-19 pandemic, Benchling provides each employee a one-time stipend of $1,000(USD) upon commencing employment, and additional discounted employee purchase plans for home-office equipment.
Protecting the health of our employees and the candidates interested in a role at Benchling is our top priority. We appreciate your understanding and being open and flexible with any changes related to our interviewing process.
For applicants for U.S.-based roles only: All new hires in the United States are required to be fully vaccinated against COVID-19 and to provide proof of vaccination prior to their first day of employment. If you are unable to be vaccinated for medical or religious reasons, we will explore potential reasonable accommodations; however, Benchling may not be able to grant such accommodations in all cases if doing so would cause an undue hardship.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We also consider for employment qualified applicants with arrest and conviction records, consistent with applicable federal, state and local law, including but not limited to the San Francisco Fair Chance Ordinance.