Manager GXP Compliance
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
This position will be the regional representative for the Corporate GxP Compliance function. Responsibilities include designing, developing and implementing cGxP-related programs to assure compliance with corporate policies and regulatory agencies. The scope of the responsibilities include management of compliance metrics, completing assigned projects to enhance compliance, and supporting inspections.
Represent the company and promote the company’s position on training programs, LMS, and training records during inspections by regulatory agencies (e.g. FDA, HPRA, ANVISA, etc.), and business partners.
Track internal audit and regulatory inspectional commitments through action, completion and verification.
Provide guidance and support to site management on the design, selection, and implementation of systems/programs as they relate to GxP compliance.
Keep abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met. Actively seek out new, cutting edge technology to further training initiatives and build efficiency.
Work closely with internal functions to ensure cGxP activities are addressed to support those functions.
Support corporate policy in which all staff are required to follow defined processes and policies; behave in a professional manner with integrity and strive for right first time performance, and where Management is required to ensure staff are assigned appropriate curricula and have a combination of training, education and experience to execute assigned responsibilities.
Support proactive compliance as the site representative for emerging regulations; compliance intelligence and site compliance metrics.
Support the Corporate recall program.
Performs a wide variety of activities to ensure compliance with applicable regulatory and requirements.
Ensure cGxP activities including QTAs, temperature releases, deviation support, site visits, and audit support are actioned in a timely manner.
Develops, implements, and maintains systems, programs and processes to ensure compliance with cGxP regulations.
Other duties as assigned
Specific GDP Responsibilities within GXP
Act as Deputy Responsible Person on Biomarin WDA Licence.
Safeguarding product users against potential hazards arising from poor distribution practices
Ensure conditions of the relevant BioMarin distribution license requirements.
Ensuring that the GDP quality management system is maintained.
Focusing on the management of authorised activities and the accuracy and quality of records.
Ensuring that initial GDP and continuous GDP training programmes are implemented and maintained.
Ensuring that relevant customer distribution complaints are dealt with effectively.
Ensuring that suppliers and customers for distribution activities are approved.
Approving any subcontracted activities which may impact on GDP.
Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
Deciding on the final disposition of returned, rejected, recalled or falsified products.
Approving any returns to saleable stock.
Ensuring that any additional requirements imposed on certain products by national law are adhered to.
Maintain current regulatory knowledge by regularly using regulatory web sites as applicable to read any changes to guideline and regulations
10+ years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions.
7+ years supervisory/management experience.
Responsible Person (or Deputy) experience on a regulatory licence.
Experience with public speaking in a small to large group setting (5 to 200).
Excellent interpersonal and communications skills required. Strong organizational and technical writing skills required.
Computer literacy required, including Microsoft PowerPoint, Word, Excel. Instructional design.
Prefer experience in manufacturing facility or regulated industry; experience managing a Learning Management System (UL ComplianceWire preferred) and CBT authoring tools.
Demonstrates strong technical and analytical skills; provides assistance to solving training/employee issues.
Results oriented; effectively manages a multitude of projects efficiently.
Demonstrates excellent negotiation skills; develops effective and supportive relationships with the departments supported.
Experience managing internal and external cGxP project stakeholders.
Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker.
Builds strong, effective working teams; builds relationships with other sites to promote training, shares best practices, and solves shared problems.
Demonstrates in-depth understanding and application of cGxP principles, concepts, practices and standards in the US and internationally.
Demonstrates substantial knowledge of industry best practices and trends.
BA/BS from an accredited school.
12+ years of experience with biotechnology, pharmaceuticals or human healthcare industries.
Advanced Degree preferred.
BA/BS or Advanced Degrees in Education/teaching, Human Performance Improvement, Human Resources, Science or technology education.
Lean and/or Six Sigma certification from a recognized certifying body or global organization engaged in Lean Six Sigma.
Responsible Person Accreditation or similar.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.