Associate Director, QA CMO- Biologics

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 Quality Assurance Contract Manufacturing Organizations (CMO) and will maintain responsibility, leadership, oversight and management of all QA-related activities at BioMarin’s CMOs that manufacture biologics (drug substance, drug product, labeling/packaging). Key responsibilities include:

1.Lot disposition decisions and batch record review
2.Deviation, CAPA, change control and master label approvals
3.Primary QA representative and liaison to CMOs and BioMarin partners
4.Oversight and management of all QA-related activities at CMOs

Up to 20% travel may be required.

RESPONSIBILITIES

Leadership

•Plan, organize, and direct the QA CMO biologics 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

•Lead QA oversight activities at relevant CMOs

•Make lot disposition decisions for Drug Substance and Drug Product lots, including

-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

•Approve deviations, investigations, CAPAs, change requests, etc. from CMOs

•Work with a multi-functional team to ensure adequate supply

•Prepare sections of annual product reviews

•Lead efforts to generate and/or revise Quality & Technical Agreements with CMOs for biologics

•Perform lot assessments as needed

•Manage and maintain good relationships with partners

•Support regulatory agency, partner and QP inspections

•Support regulatory filings

•Support product launch activities

•Support process validation activities

•Other duties as assigned

Requirements

EXPERIENCE

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, acceptable 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.

SUPERVISOR RESPONSIBILITY

•This position will oversee a group of ~ 7 full time employees (including 2 direct reports)
•This position will lead and oversee multi-functional teams associated with QA-led initiatives and efforts.

Company

BioMarin Pharmaceutical

Job Code

State or Province

California

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