AbbVie (NYSE: ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases. In 2013, AbbVie will employ approximately 21,000 people worldwide and markets medicines in more than 170 countries.
PRIMARY JOB FUNCTION:
The primary function of this position is to:
Assure that GPRD remains in compliance with Corporate and Divisional policies and procedures and all applicable worldwide regulations;
Assess the success and effectiveness of the GPRD quality system by leading compliance audits and applicable assessments (e.g. PAI readiness assessments);
Provide consultation and assistance to GPRD personnel on compliance issues.
Assist in regulatory inspections;
Provide GPRD personnel with training on applicable worldwide regulations.
Lead cross-functional project teams to help resolve issues.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
The major duties and responsibilities of this position are to:
Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures;
Plan, organize, and lead multiple audits of R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally;
Plan, organize and lead multiple audits of investigative clinical sites to assess compliance with regulations, guidelines, policies, procedures and sponsor requirements;
Review a variety of clinical research documents such as protocols and research reports to assess the quality and compliance to policies, procedures, and applicable governmental regulations;
Evaluate the potential risk of compliance deficiencies;
Plan, organize and lead audits of external contract facilities (specialty testing laboratories, central laboratories, clinical sites, central Institutional Review Boards (IRBs), Contract Research Organizations and distributors as applicable) both within the and globally;
Maintain effective communication of project related information;
Review corrective action plans/audit responses for adequacy and approve if adequate;
Review policies and procedures and suggest improvements;
Create quality/compliance training programs for the GPRD organization;
Initiate, manage, and/or participate in quality improvement projects
Work independently as well as a team;
Mentor, coach and train QA auditing staff;
Prepare and present multiple project progress reports to update management and keep the team(s) informed;
Lead/assist/manage external audits by regulatory agencies or customers;
Maintain project oversight to include assessments for the development program, allocation of QA resources and awareness of project timelines;
Supervise Quality team members for project specific activities as required.
POSITION ACCOUNTABILITY / SCOPE:
This position is accountable to the Section Manager or Manager of GPRD QA GCP Compliance.
The decisions and recommendations made by the individual will directly impact compliance to applicable regulations, and thereby promote the continued success of GPRD.
These activities such as auditing and associated functions can have a great impact on the quality of the data, which can, ultimately, lead to delay, or inability of Abbott to market new products.
SCOPE OF AUTHORITY:
This is an experienced level compliance position.
The individual is expected to identify and resolve problems through effective use of technical and interpersonal skills. The individual must be able to work independently and also be an effective project team leader. The individual has the authority to make decisions with limited supervision of management.
Limits to freedom and individual action are based on the level of expertise and interpersonal skills possessed.
Assignments will involve interacting with peers within GPRD, all levels of management as well as external organizations.
This individual may have the authority to supervise others on their team.
The job requires knowledge of quality principles, research, and the development of pharmaceuticals and an understanding of the effect of his/her decisions on it.
The Individual must be able to:
fectively handle multiple assignments simultaneously.
- Work independently, in a team environment and with all levels of personnel within the organization. Ef
Anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall project(s).
- Demonstrate a thorough knowledge of the applicable regulations and be able to apply them to a wide variety of situations.
- Successfully interact with all levels of personnel within the division.
Take initiative and identify new approaches to resolve problems (i.e., risk assessments, CAPA plans).
Utilize innovation in solving problems.
Most decisions will be discussed with management prior to action plan.
X or equivalent experience
Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent e
Why Required? A scientific background is recommended due to the scientific nature of the work and the data that will be reviewed.
Position Titles or Description of Experience
Previous experience in QA/RA
preferred or experience in clinical research development
QA Auditing Experience (GCP Auditing Preferred)
Total combined minimum years experience preferred
(Not necessarily the sum of the above)
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
Yes, 25 % of the Time
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories.Together with its...