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Senior Manager, Quality and Compliance (Clinical)

Apply now Job no: 615402
Work type: Permanent
Location: Boston, Massachusetts, Lone Tree, Colorado, Los Angeles, California, Minneapolis, Minnesota
Categories: Clinical Studies, Quality & Regulatory, North America, Individual Contributor

Clinical Quality & Compliance Manager (Senior Manager, Quality and Compliance (Clinical))

Position Spotlight:

  • Support the execution of Cochlear clinical evidence QMS activities 
  • Lead FDA/Health Canada inspections, internal Quality audits & applicable corrective actions
  • Guide and train Good Clinical Practice (GCP) and QMS process compliance
  • Hybrid or remote work environment dependent on place of residence 

Change people’s lives and love what you do!  Cochlear is the most recognized brand in hearing health care.  

About the role  

As Cochlear continues to grow and service our customers, we are recruiting for a Clinical Quality & Compliance Manager in our Americas head office based in Lone Tree, CO (CAM). 

To be successful in this role you’ll be able to communicate and teach the importance of Clinical Compliance in the execution of clinical evidence activities to regional project teams as well as collaborate globally with Clinical Quality & Compliance team members on the development, deployment, and maintenance of quality management processes.  This role is responsible for Clinical Quality & Compliance essential functions that support pre- & post-market clinical evidence activities conducted in North America.  

Key Responsibilities 

  • Maintain compliance and facilitate improvements for efficiency in clinical investigation Quality Management System (QMS) processes as the CAM regional representative. Ensure consistency and adherence to clinical research guidelines and standards.   
  • Conduct operational activities as assigned to the regional Clinical Quality Manager process role to support execution of Cochlear clinical investigations and clinical evidence activities. These responsibilities include but are not limited to timely and accurate document quality control checks as well as working with external vendors for the supply services according to Cochlear supplier and procurement processes.  
  • Manage FDA or Health Canada inspections and internal Quality audits through collaboration with CAM Quality and Clinical Project teams. Be responsible for any applicable quality responsibilities such as corrective actions or required responses that result from inspections findings.   
  • Be the champion for Good Clinical Practice (GCP) and QMS process compliance for each regionally executed clinical investigation.  
  • Participate in and support global Clinical Quality and Compliance core activities and initiatives, including metrics and management reviews.   

Key Requirements  

To add value to Cochlear in this role you'll be able to meet and demonstrate the following knowledge, skills and abilities in your application and at interview: 

  • Bachelor’s degree in Communication Disorders, Health Sciences, Nursing, Public Health or equivalent with a minimum of 7 years of relevant work experience in the medical device or pharmaceutical industries or an advanced degree such as a Masters in the applicable areas of higher education plus 5 years of relevant work experience.  
  • Current certification with an applicable industry society such as CCRP, ACRP, CPHQ, ASQ or RAPS is preferred.  
  • Prior experience with Competent Authority (e.g., FDA and Health Canada) inspections including strong verbal presentation and written communication.   
  • Competency in either pharmaceutical or medical device regulations including 21 Code of Federal Regulations Part 812 or 312, Health Canada and ISO Good Clinical Practices.  
  • Previous work experience with Quality management processes such as NCR, CAPA or other associated performance Clinical Quality metrics.  
  • Ability to travel minimally 1 week per month to the Lone Tree office with additional travel that falls within the scope of the position.

Work Environment

This role is 100% remote for candidates who live outside of Colorado, or those with an excessive commute outside the Denver Metro Area. Remote candidates must have the ability to travel minimally 1 week per month to the Lone Tree office. A hybrid work environment of two days in office each week is available to candidates who live within the Denver Metro Area and have a reasonable commute to the office. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Salary and Benefits

In addition to the opportunity to develop your knowledge and grow professionally, we offer competitive wages and benefits.

  • The Target Salary Range: $120,000 – $130,000 based upon experience as well as a bonus of 15% of base salary.  Compensation offered to candidate may vary based on work experience, education and/or skill level.
  • Benefit package includes medical, dental, vision, life and disability insurance as well as 401(K) matching with immediate vesting, Paid Time Off, tuition reimbursement, maternity and paternity leave, Employee Stock Purchase Plan and pet insurance.

COVID-19

In alignment with our organizational principle of providing a safe work environment, employees of Cochlear are required to be fully vaccinated against COVID-19. The only allowable exceptions include qualifying medical and religious accommodation. Proof of your COVID-19 vaccination will be required when you begin employment.

Who are we?

Human needs have always been our inspiration, ever since Professor Graeme Clark set out to create the first multi-channel cochlear implant because he saw his father struggle with hearing loss. We always start with people in mind – thinking about their needs.

For this reason, our products, services and support will continue to evolve and improve. We are by our customers’ side through the entire hearing journey, so they can experience a life full of hearing. Our employees tell us that the number one reason they enjoy working for Cochlear is the opportunity to make a difference to people’s lives and working in an organization where they can be part of bringing the mission to life each day.

Physical & Mental Demands 

The physical and mental demands described below are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the individual is regularly required to be in a stationary (seated/standing) position; utilize business technology for work product delivery; communicate orally and in writing with others internal or external to the organization; and utilize problem solving and critical thinking skills to discern and convey information.  Specific vision abilities required by this job include ability to adjust focus. The individual is regularly required to utilize comprehension, critical thinking, communication, problem solving, organization reasoning.  Influence, organization & classification of information, and planning are also required.   

The work environment is a home/office environment and are representative of those individual encounters while performing the essential functions of this job.  

Apply now by completing your application form online. Applicants must meet the job specific application criteria to be considered. Visit our careers site at www.cochlear.us/careers to learn more.   

Cochlear Americas is an Equal Opportunity, Affirmative Action Employer and provides equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, marital status, veteran status, or any other characteristic protected by federal, state or local law.  In addition, Cochlear will provide reasonable accommodations for qualified individuals with disabilities.  If you require accommodation with completing the online application, please contact us via web or phone at 303-264-2549. 

Advertised: Mountain Standard Time
Anticipated Application Closing:

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