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Lead Compliance & Quality Manager, Cerner Enviza

Virtual New Jersey, New Jersey, United States

Job Description

Cerner Enviza is looking for a Compliance & Quality Leader in the US, primarily responsible for quality management and compliance oversight in clinical research, Real World Research (RWR) and Market Research (MR). Including but not limited to - ISO recertification, pharmacovigilance (Adverse Event reporting), data privacy (state and federal level), GCP, GEP, GPP and GVP, vendor management, internal and external training, SOX compliance, FDA regulations, HIPAA and pharmaceutical client requirements.

Responsibilities:
  • Lead quality and compliance affairs in the US across commercial, clinical and RWR domain functions over 300 associates.
  • Responsible for implementing quality processes & ensuring adequate application
  • Responsible for ensuring that all projects handled are in line with Cerner Enviza SOPs
  • Perform internal and external auditing based on instructions set up Cerner Enviza’s quality system, for example, ISO, PV, FDA readiness.
  • Responsible for ensuring compliance with pharmacovigilance requirements
  • Lead, direct and review the team’s work to achieve operational or functional targets or objectives with significant contribution towards the achievement of immediate and short-term results for the team, department domain and organization
  • Establish and communicate team or domain department goals that support and advance team, department domain and organization objectives; establish metrics or other performance measures to track progress
  • Influence diverse stakeholder groups and drive acceptance of policies, practices and procedures within broader area of responsibility
  • Identify, propose and lead team- and domain level quality and process improvement initiatives; lead or influence strategic initiatives at the domain level and provide input on strategic initiatives for the organization
  • Deliver consistent and timely training, guidance and feedback to encourage success and promote associate growth through regular domain developmental conversations and identification of domain developmental opportunities
  • Maintain and developing quality and compliance documentation, e.g. SOPs, template, working instructions, organize and deliver training (internal, external to our vendors, from clients and industry guidelines.
  • Own decision-making for staffing and performance decisions for direct reports
  • Manage one or more teams of associates
  • Work closely with global quality and compliance units in Europe, APAC and LatAm, report directly to Global Head of Compliance and Quality, DPO.

Working Environment

REMOTE

This position offers a Remote working environment. Meaning you can live and work in your current geographical location and work primarily remote. There could be times you will be requested to travel and/or visit a Cerner office or client site. #Remote

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Because It's Personal

Time: 2:57

Additional Information

Working Environment REMOTE
Relocation Assistance Available for this Job: No

Qualifications

Basic Qualifications:
At least 10 years total combined related work experience and completed higher education, including:
  • At least 3 years compliance, regulatory affairs and/or quality management work experience
  • At least 7 years additional work experience directly related to the duties of the job and/or completed higher education

Desired Qualifications:
  • Master’ degree (or equivalent) in finance, legal, technology, business or a related field.
  • 5 years’ experience in quality and compliance management

Expectations:
  • Candidate must have strong skills inwritten communication with a demonstrated ability to write clearly and succinctly;
  • Comprehension skills – able to read large quantities of documents and summarize them to actionable bullet points
  • Organizing skills – maintain documentations in organized fashion
  • Leadership skills – lead US compliance and quality function
  • Candidate must demonstrate intellectually curious, self-motivated and able to work autonomously to achieve results

Applicants for U.S. based positions with Cerner Corporation must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available for this position.

As a condition of employment, all US-based employees must be fully vaccinated against COVID-19 unless a medical or religious exemption is approved.

Some Cerner positions may be obligated to comply with additional client-facing requirements and occupational health requests, including but not limited to, an immunization set, an annual flu shot, an annual TB screen, an updated background check, and/or an updated drug screen.

Cerner is a place where people are encouraged to innovate with confidence and focus on what is important – people’s health and the care they receive. We are transforming health care by developing tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health. From single offices to entire countries, Cerner solutions are licensed at more than 25,000 facilities in over 35 countries.

Cerner’s policy is to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Cerner is proud to be a drug-free workplace.

EEO is the Law with Supplement (English)
E-Verify Participation (English)
Right to Work (English)
Pay Transparency Nondiscrimination (English)

EEO is the Law with Supplement (Spanish)
E-Verify Participation (Spanish)
Right to Work (Spanish)
Pay Transparency Nondiscrimination (Spanish)
If you are an individual with a disability who is unable to use our online tools to search and apply for jobs, and need assistance or an accommodation in the recruiting process, please contact us by calling 866-434-1543 or by emailing CernerCareers@cerner.com.

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