Associate Director, QA CMO

Job Description
Job Description

BioMarin leads the biotechnology industry in delivering therapies for chronic and degenerative genetic conditions that reduce patients' quality of life and shorten life spans. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. BioMarin will continue to focus on advancing therapies that are the first or best of their kind and make a big difference in improving patients' lives.

SUMMARY

This position reports to the Director of QA CMO and will maintain functional responsibility, leadership and management for multiple QA CMO systems related to commercial and clinical small molecule products/programs. This position will be the primary contact held responsible and accountable for all QA CMO activities related to small molecules at BioMarin.

RESPONSIBILITIES

Leadership

•Plan, organize, and direct the QA CMO Small Molecule group

•Take the initiative to create and implement a plan to enhance, optimize and improve QA CMO systems

•Establish operational objectives and metrics

•Establish effective communication and collaborative relationships with other functional groups and key stakeholders

•Represent QA CMO and participate in multi-departmental meetings

•Develop, define, and enforce departmental policies and practices for functional groups

Management

•Forecast and help manage cost center budget and staffing needs (internal and external)

•Hire, train, develop, evaluate, discipline, and support supervisors and employees in group
•Establish performance goals and strategic/operational objectives for direct reports based on company and departmental goals

•Evaluate and handle employee performance, productivity and complaints

•Train employees in inspection requirements and promote technical development

Technical/Functional

•Release Drug Substance and Drug Product lots without disrupting supply. This objective will run throughout the year and may be accomplished by doing the following:

-Timely review of batch records associated with DS, Bulk DP and packaged and labeled DP

-Timely release and issuance of CofC of DS and DP lots

-Perform the above goals with no deviation related to review and release of any DS and DP lots.

•Prepare annual product reviews

•Lead efforts to generate and/or revising Quality & Technical Agreements with CMOs for small molecules

•Perform lot assessments as needed

•Support Regulatory filings

•Support product launch activities

•Support regulatory agency, partner and QP inspections

•Support process validation activities

•Other duties as assigned

Requirements
Required Skills:

•12+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency of quality systems, lot release and quality activities.

•7+ years experience in a management or supervisory position, with direct experience overseeing quality assurance activities.

•Excellent leadership, technical, management, problem solving and project management skills

•Organizational and management skills to handle multiple functional groups, with ability to effectively delegate work

•Ability to speak, present data, and defend approaches in front of audiences and inspectors

•Strong report writing skills, adequate for regulatory review

Desired Skills:

•Experience in participating in regulatory inspections, presenting/defending departmental functions in audits or regulatory inspections (specific experience in defending quality systems preferred, but not required)

•Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for departmental functions (understanding of regulatory guidelines for other countries a plus)

EDUCATION

BS or BA in a technical discipline; advanced degree preferred.

CONTACTS

This position will require interaction with multiple levels (from entry level employees up to Senior/Executive Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Contract Manufacturing, Regulatory Affairs, Clinical Operations, Pharmacovigilance, Medical Affairs, Legal, Accounting, Finance, and Human Resources.

SUPERVISOR RESPONSIBILITY

•This position will oversee a group of ~ 3-4 full time employees (including 1-2 direct reports)
•This position will lead and oversee multi-functional teams of ~ 12+ people.

Company

BioMarin Pharmaceutical

Job Code

State or Province

California

Apply
 Print  Close
Terms and Conditions I ©2000-2025 Candidate Seeker, Inc. I ©1994-2025 Brolin Corporation
   Powered by Portal Prodigy