1. Manages quality systems and regulatory affairs activities which may consist of; Material Review Boards (MRBs), licensure/ registration activities and the review of records, processes and systems.
2. Hires, mentors and develops QA staff and educate QA/operations staff on quality principles and regulatory requirements.
3. Prepares for, hosts and closes out internal and external inspections/audits and participates in the response to internal/external audit observations.
4. Represents QA and/or leads projects, work groups or multi-functional process improvement, change control, consolidation and standardization teams.
5. Works collaboratively with Operations and Problem Management in problem solving activities or functions.
6. Stops the manufacture and/or distribution of biomedical products/services should it be determined that the SQuIPP of the product or process has been compromised.
7. Perform related duties as assigned.
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be an exhaustive list of all responsibilities and duties required of staff so classified.
Performs job responsibilities with no supervision and exercises independent judgment. Manages professional, administrative and operational staff. Coaches and provides guidance on quality issues to operations and Quality staff. Assure that departmental employees are adequately trained and adhere to all company, local, state and federal regulations and OSHA standards. Handles issues at multiple sites within region. May interface directly with the Executive or Senior Management. May serve as Quality Director. Requires a high level of interaction with all levels of the organization. Maintains activities within prescribed budgetary constraints; indirect budget responsibility.
The duties and responsibilities mentioned in the job description are representative of the essential functions of the position. The performance management system incorporates competencies which are identified, discussed and evaluated in order to meet operational milestones and which are tied to job families and titles. Three types of competencies have been identified; Technical Competencies are job specific skills and methods, Core Competencies are the abilities and behaviors expected of all Biomedical Services employees, Leadership Competencies are specific abilities and behaviors required of those performing formal management roles or other leadership roles (i.e. Project Leaders). Management and staff should contact Human Resources for further details on the appropriate competencies for a specific position.
Essential Functions/Physical Requirements:
The duties are representative of the essential functions of the position. Physical requirements are those present in normal office environment conditions. Operational flexibility is required to meet sudden and unpredictable needs.
Exposure levels are based on the essential functions as stated in this position description; however, in some instances, variances may occur due to the applicable nature of this position within a particular work site. Therefore the work site may determine the exposure level to be greater than or less than the below stated level.
This position is an exposure determination 1 in view of the fact that normal work involves potential exposure to blood or blood components and/or human body fluids or tissue samples as a result of splashes, spills, and/or needlesticks or performance of or assistance in first aid.
The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Bachelors degree in applicable field of study or equivalent related experience. Five years of experience in a cGMP environment such as blood, plasma, tissue, pharmaceutical or medical device firm. Four years functional experience in QA, Quality Control (QC) or QA Auditing. Three years management experience. Demonstrated superior verbal and written skills. Knowledge of operations in a biologics, pharmaceutical or medical device manufacturing environment. Knowledge of federal regulatory requirements and quality assurance practices/principles related to medical industry manufacturing operations. Courses and practical experiences in leadership role. Must display tact, diplomatic and professionalism in difficult situations. Must protect the confidentiality of sensitive information in the department. Must operate as a team member. Ability to travel up to 50%