Quality Assurance and Compliance Manager

MERIT is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities

MERIT is seeking a full-time Quality Assurance and Compliance Manager; primary functions include collaborating with the Executive Management and Project Managers to implement and maintain the Quality Management System (QMS).  Provides directives, support and training that meet regulatory requirements including Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and ISO 13485 and 27001. Oversees the Quality Assurance and Compliance (QAC) department and ensures resources for contractor and vendor assessment activities including qualifications, audits, internal audits, and vendor and contractor maintenance activities. Acts as the primary contact for conducting client and regulatory audits.  Provides training and communications on regulatory requirements to MERIT personnel. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: (Other duties may be assigned.)

• Understand the EXCELSIOR™ product, protocol and conduct of clinical trials in sufficient detail to be able to adequately discuss, direct and manage task items with the project managers and team members
• Manage Quality Assurance and Compliance team 
  • Monitor workload across projects and ensure appropriate coverage
  • Contribute to maintenance and development of Quality Assurance Validation training program and procedures
  • Identify staffing needs and manage career postings and development of Quality Assurance positions
  • Interview and contribute to final hiring decision of new Quality Assurance staff
  • Set performance standards for Quality Assurance team and ensure employees understand their duties
  • Monitor employee performance and routinely provide constructive feedback and coaching
  • Manage corrective, disciplinary, or termination activities including notification to Executive Team and Human Resources for employees
  • Monitor internal contractor performance and adherence to expected outcomes
• Participates in with operational and strategic business directives, including assisting with the completion of Client Questionnaires and Request for Information (RFIs).
• Contribute to Management Review Meeting content and data collection
• Leads the hosting of client and regulatory audits including managing schedules, responding to audit responses, and organizing audit records. 
• Comply fully with MERIT policies and Standard Operating Procedures (SOPs)
• Internal audits - Develop annual internal audit schedule and facilitate the resources for conducting audits and have ability and knowledge to perform internal audits
• Vendor and Contractor qualifications and audits – maintain vendor and contractor review schedules and manage resources for the conduct of vendor and contractor qualifications and audits
• Provide training for implementation of internal and regulatory requirements
• Ensure that SOP(s) are being followed during daily operations: CAPA, deviations, non-conformances, document control, change control, software development life cycle, validations, training, security, and documentation 
• Interpret and implement regulatory guidelines into MERIT QMS
• Schedule, manage and act as MERIT representative during client and regulatory on-site visits and audits
• Responsible for audit responses within framework of internal SOP(s) and client due dates 
• Responsible for the management and maintenance of personnel files, including new employee      orientation, signature list, SOP reading lists, and ongoing employee development training records
• Other responsibilities may be assigned as required 

The following are the essential functions of the position but are not all-inclusive.

• Practices and responds with commitment and sensitivity toward satisfying the needs of internal and external customers. Promotes quality and continuous improvement philosophy.
• Demonstrates a commitment to maintain safe, clean and orderly work area. Promotes and follows safety regulations and actively contributes to work safety.

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience:

BA or BS degree from a four-year college or university with related experience and/or training in a health related, biological science, clinical research, or service related environment. 

Preferred experience in clinical trial and/or regulated pre-clinical research field. 

A minimum of five (10) years of quality assurance experience in the medical device, pharmaceutical, or a GxP industry preferred. 

Other Skills and Abilities:

• Proficient computer skills
• Ability to Lead a Team
• Knowledge of clinical trial data management systems is preferred
• Knowledge of GCP preferred
• Knowledge of GxP preferred
• Excellent interpersonal and customer service skills
• Excellent communications skills, both oral and written 
• Ability to problem solve 
• Ability to multi-task and balance priorities to meet timelines
• Ability to work independently 
• Ability to work within a team, often taking a leadership role
• Ability to both give and receive critical feedback 
• Must possess managerial decisiveness to prioritize on multiple projects

Licenses or Certifications Required: 

None.

Physical Requirements: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job

While performing the duties of this job, the employee is regularly required to use hands; to touch, finger and grasp, handle or feel, with repetitive motions, and talk or hear. The employee is frequently required to stand; walk and sit. The employee is occasionally required to reach with hands and arms, stoop, crouch, kneel and climb. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Benefits Offered: 

401(k)

Dental insurance

Disability insurance

Health insurance

Life insurance

Paid time off

Vision insurance

 MERIT CRO, Inc. is an equal opportunity employer, and we are committed to hiring a diverse and talented workforce. It is the employment policy and practice of Merit to recruit and hire qualified employees without discrimination based on race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, national origin, ancestry, citizenship status, age, mental and physical disability, pregnancy, medical condition, genetic information, political affiliation, union membership, status as a parent, marital status, military or veteran status, or other classes protected by applicable law, and to not discriminate concerning compensation and opportunities for advancement, including upgrading, promotion, and transfers. We will provide reasonable accommodation to qualified individuals throughout the application, interviewing, and employment process. If you require reasonable accommodation, please contact us.