Quality Systems Manager

Job purpose Directly responsible for managing the daily operations of the document control, change control, and training system processes and procedures. Implements and directs documentation procedures in storage, revision, retrieval, and release of records. Acts as the owner of the change control process through initiation, approval, and closure. Owner of the training process responsible for managing training administrative work and assisting departments in developing training processes to standardize organizational training and documentation. Serve as a resource for the development and advancement of training programs offered to our employees and customers.


Requirements

Applicants must be legally authorized to work in the United States. Vivex will not provide sponsorship or employment for candidates who require the 24-month STEM Optional Practical Training (OPT) extension. Please note this is not an offer of immigration sponsorship.

Duties and responsibilities

Job Role Specific

1. Oversee and support Document Control, Change Control, & Training staff for program success and compliance.
2. Manage document, change control, and training operating procedures and databases.
3. Manage the approval and release of labeling components.
4. Participate in the development, improvement, and roll-out of DMS and training tools.
5. Execute and enforce security protocols for the access, storage, backup, maintenance, reproduction, protection, and disposition of all documents to comply with AATB, FDA, and state regulations.
6. Collect and report on metrics related to the state of the DMS[LA1] [LC2] and Training System.
7. Collaborate with interdepartmental stakeholders during project development and execution as it relates to Document, Change Control, and Training Program Management.
8. Assist employees with registration and preparation activities for the Certified Tissue Banking Specialist exam.
9. Other functions and responsibilities as assigned.

Quality Assurance

1. Maintain knowledge of and support Vivex Biologics, Inc. (Vivex) policies and procedures.
2. Maintain knowledge of appropriate regulatory, statutory, accreditation requirements, and current Good Tissue Practices (cGTP);
3. Support site inspections by FDA, AATB, State, and other Third-Party Agencies;
4. Responsible for reporting all variances, errors, and deviations on all Vivex initiated documentation according to procedure.
5. Participate in the investigation, implementation of corrective actions, and documentation of complaint files and nonconformance reports, as needed;
6. Perform other duties as assigned.

Qualifications

Education:


• Bachelor's Degree required or 5+ years [LA3] [LC4] of experience in an FDA regulated industry;

Experience:


• 3+ years of experience in Document Control, Change Control, and/or Training, preferably in Tissue Banking, Biologics, Medical Devices or Pharmaceutical industry;


• Strong knowledge of quality systems and regulatory requirements (21 CFR Part 11 / 210 / 211[LC5] [LA6] / 820);

• Experience with document or learning management system preferred.

Skills:

• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment as a leader;

• Ability to work on multiple assignments in collaboration with other departments with the successful completion of projects;

• Strong organizational skills and attention to detail a must;

• Excellent technical writing and editing skills;

• Advanced computer and word processing skills with MS Word;

• Strong working knowledge of Microsoft Excel, PowerPoint, Visio;

• Experience with Adobe Acrobat, Adobe Sign, SharePoint preferred;

Licenses/Certifications:

CTBS or ASQ certification preferred.

Working conditions

On-site. Primarily a quiet office work environment. Some evening and weekend work may be required. Facility temperatures are maintained cool.

Physical requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.


Direct reports

Document Control Specialists, Change Control Coordinator, and Training Systems Coordinators

Nothing in this job description restricts management's right to assign or reassign duties and


responsibilities to this job any time.


Vivex is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.

Vivex complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.