The Senior Manager, Quality and Compliance will be responsible for driving and maintaining ClinOne’s quality and compliance program, managing internal and external audits, maintaining certifications, and ensuring compliance with all applicable regulatory requirements and global standards.
- Responsible for overseeing and managing ClinOne’s Quality Management System and ensuring compliance with all applicable regulatory requirements and equivalent global standards
- Organize and lead risk, privacy, and compliance training programs to educate and inform employees about best practices and standards.
- Effectively initiate and support process improvement initiatives, to support continuous improvement throughout the organization
- Provide effective leadership support, training, and guidance to all ClinOne teammates with respect to quality and compliance
- Proactively develop, lead, and drive the execution of global regulatory and quality strategy with a focus on efficient, timely delivery of products and services, including recommending, obtaining, and maintaining relevant industry certifications.
- Develop and oversee ClinOne’s Quality Audit program including Vendor Management oversight.
- Oversee and administer the Quality Event investigation process, including management of the incident and follow-up actions (CAPA)
- Support the business:
- By assisting in the review and response to security questionnaires and regulatory questions from customers
- By collaborate closely with leaders in each business unit to understand what customers they serve and how data that they process and retain is categorized and used, implementing process to meet all applicable regulatory bodies.
- By recognizing and responding to compliance issues in a timely manner
- Supervise, manage, and direct the work of direct report(s) with responsibilities associated with compliance, auditing, and investigations.
- Bachelor’s degree is required, preferably within Life Sciences and or related field
- Advanced degree or certifications preferred
- A minimum of 10 years in pharmaceutical/biotechnology corporate quality and compliance roles, with progressive experience and focus within quality/compliance monitoring, auditing, and investigations
- A minimum of 5 years of experience managing direct reports
- Demonstrated experience and expertise with detecting and presenting trends/patterns related to auditing, monitoring, and investigations findings at a high level and in detail, dependent upon audience
- Demonstrated knowledge of the pharmaceutical/bio-tech regulatory and compliance requirements
- Experience developing, deploying, and maintaining quality and compliance program policies
- Strong interpersonal and communication with clear, concise writing and presentation skills
- Ability to build professional relationships with internal customers and partners
- Life science and biopharma and clinical research background
- High attention to detail and level of accuracy
- High degree of tact, judgment, and discretion
This is a remote position.
ClinOne provides a suite of technologies to dramatically simplify and accelerate clinical trials. We are streamlining the communications and processes for sponsors, research sites, participating physicians and, most importantly, for patients. We are helping accelerate clinical studies and saving lives.
How to Apply
Please submit your cover letter and resume to email@example.com or apply online.