Location:
Novato, CA
Posted Date:
4/26/2012
Position Type:
BS FULL TIME
Job Code:
12-0001
Required Education:
High school or equivalent
Areas of Expertise Desired:
Description
BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employee’s contribution toward reaching our corporate mission—to develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.
Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.
EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 12-0001
SUMMARY
The Manager GLP Compliance’s primary responsibility is to support the GLP Compliance (GLPC) audit/inspection activities required for the effective execution and completion of IND and/or CTA submissions.
The incumbent will manage creating audit/inspection plans, and independently manage and conduct external, domestic and international GLP audits to assess the company's compliance to FDA Good Laboratory Practice (GLP) regulations and OECD guidelines. The Manager GLP will also organize and perform internal system Sponsor inspections and manage audit schedules; report to management inspection observations and overall GLP compliance risk; participate in establishing and developing a GLP training program; coordinate the metrics development system; support FDA and/or other regulatory inspections.
This position requires a high level of organization and concise communication skills since the successful management of GLP Compliance will be achieved by building and maintaining strong relationships with multiple internal and external team members and cross functional groups. This individual is an active participant in project teams and sub-teams as the key point of contact.
Strong knowledge of GLP Regulations, verbal and written communication, and organizational skills are required. In order for this candidate to be successful in this position, the candidate should possess dynamic interpersonal and teamwork skills.
Mature, problem solving attitude; exhibits judgment and a realistic understanding of the issues; able to use reason even when dealing with emotional topics and has interpersonal skills.
This individual will also be directly involved in the continued development and refinement of the GLP Compliance QA SOPs and policies.
RESPONSIBILITIES
This position’s responsibilities includes, but are not limited to the following:
• Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensures schedules and performance requirements are met.
• Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions and/or customers. Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
• Leads an external and internal facility, process-based and study-specific data audits. Participates in complex, higher-level systems audits as defined by GLP Compliance senior management.
• Performs quality assurance reviews of protocols, amendments, final study reports, data base audits, and additional study-specific and/or global process documents as requested.
• Ensures that GLP studies are conducted in collaboration with the CRO Quality Assurance Unit (QAU), as appropriate.
• Lead role in supporting FDA and other regulatory inspections, acts as a liaison with the FDA during inspections. Provides eTools/documents that support Inspection Readiness preparation activities of GLP operation departments.
• Participates in establishing and developing a GLP training program. Provides and coordinates GLP regulatory compliance training.
• Ensures that system reviews and approvals are managed to meet project timelines and efficiently and effectively captured all respective requirements.
• Plans and manages the GLP Compliance audit plan/schedules.
• Assesses findings identified during an audit/inspections, and presents a summary in a logical and meaningful manner to the study personnel, Study Director and management.
• Prepares, reviews and distributes written audit reports written by the staff and consultant auditors. Evaluates, tracks and ensures closure for all audit reports.
• This position is also accountable for routine periodic reporting to management regarding audit/inspection findings and corrective action progress, as well as overall GLP compliance risk.
• Trains and mentors staff, as assigned. Trains GLP Compliance Specialists in the review of various regulatory documents and conduct of GLP inspections. Provides GLP training and guidance for overall career development.
• Has the ability to effectively multi task as well as a desire to work in a fast paced dynamic work environment. Excellent written and verbal communication skills are required. Domestic and international travel: 35%.
• Proactively identifies, anticipates, troubleshoots and suggests solutions for study related issues that arise while appropriately managing internal and external relationships.
• Acts as a subject matter expert by providing GLP Compliance advice to Management including updates for GLP regulations.
• Reports significant and/or serious ongoing quality deficiencies to Development Sciences Compliance Management, either by formal or informal presentations.
Requirements
EDUCATION
Minimum/Required: Bachelor’s (BS) in Life Science or closely related field of study
EXPERIENCE
Minimum/Required
• A minimum of 8 years work experience in an FDA GLP regulated Industry, pharmaceutical, biotechnology or contract research organization or equivalent. Requires a BS degree in scientific discipline. At this level a graduate (MS) coursework may be desirable.
• A minimum of 2+ years supervisory/management experience, actively participating in a GLP Quality Assurance/Compliance capacity.
• Technical skills in GLP compliance and QA discipline and accomplished computer skills.
• Thorough knowledge of FDA Good Laboratory Practices Regulations, OECD Guidelines and country-specific requirements.
• Experienced in inspection readiness activities and supporting the FDA or other regulatory inspections.
• Must have effective communication and interpersonal skills and have extensive experience in driving issues to solutions. Also, must be able to partner with a diverse group of staff/ consultants with different strengths and skills.
• Must have the ability to prioritize work and manage multiple projects while maintaining quality.
• Experience in developing, writing and implementing SOPs.
• Proven organizational skills and the ability to manage multiple projects and multiple tasks simultaneously.
• Experience fostering and maintaining professional relationships with internal and external collaborators in order to complete the given tasks.
• Ability to train employees and motivate others, relate professionally with people, compose letters/memorandum, coordinate events, apply organizational skills, research information, have time management and supervisory skills.
• Experience developing and delivering effective oral and written presentations.
• Ability to work independently and as part of a team in a very busy work environment.
• RQAP-GLP or other applicable certification or registration is desirable.
To apply: Visit www.BMRN.com Job Code 12-0001
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