Regulatory Compliance Associate

GRIFOLS, S.A.

5d•$73,913 - $85,000•Onsite

About The Position

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Job Summary: This position will be responsible for supporting internal cGxP, domestic and international supplier audits as well as compose audit responses and corrective actions to ensure company compliance with internal processes. This position will include the following major areas of responsibility: Support internal cGxP audits. Support domestic and international supplier audits. Participate in customer, third party, and national or international regulatory agency audits. Prepare quality agreements. Prepare reports Responsibilities will include writing summary reports (including trends, tables, graphs, and slides), participating in the audit response and corrective action process, and verifying the implementation and effectiveness of corrective actions. Additional roles include writing and revising documents and procedures, conducting training on procedures, cGxP, industry standards, hold and attend meetings, give presentations. This position will interface with others in and out of the company up to the vice president level.

Requirements

Bachelor’s degree in one of the Life Sciences, Health Care or other Science or Engineering fields, or the equivalent of two years of industry experience is preferred.
Industry experience within the Pharmaceutical, Biologics, Medical Device or Health Care Industry, which applies Quality Assurance or Quality Engineering practices.
At least 5 years of experience in Regulatory Affairs, Compliance, Quality Engineering, Quality Control or Quality Assurance with emphasis on conducting cGMP and GLP audits of Manufacturing, Laboratory and Warehouse operations internal to companies and/or suppliers.
Working knowledge and understanding of concepts of GxP (e.g.cGMP and GLP). These practices should include other appropriate governmental and/or industry such as (ASQ, RAPS, CPA, ISO etc.).
Understanding of industry standard operational/manufacturing practices. Knowledge of US regulations and practices pertaining to the manufacture and testing of pharmaceutical and biologics products. Familiar with ISO requirements.
Good, verbal, written and negotiations skills.
Computer literacy with proficiency in MS word, Access, and knowledge of Excel and PowerPoint.
Able to work independently with minimal supervision.
Well-developed communication skills especially in stand-up presentation or facilitation.
Lead person qualities and interpersonal skills, being able to direct the work of others.
Willing to adhere to Manufacturing and QC Laboratory gowning procedural requirements.
Demonstrated leadership skills with the ability to motivate, guide, train, and coach department personnel.
Ability to work independently with minimal supervision.
Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis.
Must be proactive, results oriented, and have strong attention to detail
Self-starter with strong work ethic and the ability to exercise good judgement.
Ability to effectively prioritize and manage multiple tasks to meet targeted timeframes.
Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment.
Must be flexible with working hours/shifts to accommodate the 24-hour, 7-day plant operation.

Nice To Haves

Specific experience with SAP preferred.

Responsibilities

Support and/or perform internal and GLP compliance audits of GB's manufacturing, testing and warehouse facilities and operations.
Support and/or perform cGMP and GLP compliance audits of GB's suppliers and contract laboratories.
Coordinate, schedule and participate in audit activities associated with GB's customers.
Participate and assist in the activities associated with regulatory inspections of GB.
Coordinate and participate in corporate audits.
Support and facilitate the development, coordination and presentation of training programs within the areas of responsibility for the department and for others.
Maintain current knowledge of regulatory and industry standards, trends and advancements.
Perform walkthrough of all GxP areas (e.g. manufacturing, quality control, warehouse, facilities, and operations) to evaluate areas are in a state of compliance with applicable regulations.
Follow up audit reports and related documents, assist with audit responses, verify the appropriateness of the implementation and effectiveness of the corrective and preventative actions.
Evaluate all GxP areas for its effectiveness in achieving the quality objectives established, as well as compliance with the applicable regulations.
Support the preparation, performance, and responses, and CAPA management to corporate quality audits.
Support supplier audits.
Follow up on reports and related documents verify the appropriateness of the implementation and effectiveness of the corrective and preventative actions.
Maintain professional and good working relationships with suppliers.
Participate and assist in the activities associated with external inspections.
Coordinate audit preparation and post audit activities.
Track and follow up on corrective and preventive actions, near misses derived from external inspections, including CAPA tracking.
Negotiate terms with suppliers.
Coordinate with and obtain legal input.
Track and follow up status.
Draft and revise quality agreements.
Evaluate quality agreement for its effectiveness in achieving quality objectives established, as well as compliance with the applicable regulations.
Maintain the CAPA program for CAPAs related to audits.
Follow up with responsible management to ensure timely and complete corrective actions.
Hold CAPA meetings and present issues to management.
Process change notification originating from sister companies.
Issue notifications to applicable customers for internal changes.
Issue and review supplier corrective action reports related to raw material issues.
Follow up with suppliers.
Evaluate the acceptability of supplier investigations and corrective actions.
Follow established regulation, procedure, training, and due date.