Description

JOB DESCRIPTION

Job Title:

Technical Manager

Department / Cost Center:

External Quality / 613

Reports to (Job Title):

Director, CTO and In Market Release

Job Code:

Location:

Turkey

Date Prepared:

07JUL2023

Full-Time Part-Time

Regular Temporary

Exempt Non-Exempt

SUMMARY DESCRIPTION

State the overall function or purpose of the job.

The Technical Manager reports to a Director of External Quality and is responsible for the successful processing, planning, monitoring, and execution of in-country testing requests by the Heath Authority Central Labs and activities that meet the needs of BioMarin’s internal customers for these efforts. This role’s core focus is processing and completing Heath Authority Central Lab testing requests, coordinating and collaborating with internal functions, timely communication to stakeholders, and escalating challenges and issues as needed.

The Technical Manager is responsible for planning and logistic of multiple, concurrent global launches where in country testing is required by the Health Authority. The project management of the requests shipped to the requester include: documents, supplies, reagents, standards, samples and other items as needed by the Central Labs.

RESPONSIBILITIES

List the major responsibilities of the job.

The responsibilities in the role include the following:

• Project manage the activities associated with multiple Health Authority Central Labs testing requests in support of product launches globally
• Coordinate with various internal stakeholders to define, gather, and manage the logistics of the requests (documents, supplies, reagents, standards, samples, etc.) to the appropriate authority
• Monitor various Central Lab testing requests to ensure timely deliverables
• Ensure timely communication to various stakeholders
• Escalating challenges and issues as needed
• Perform administrative quality function activities
• Perform other activities as needed

SCOPE

Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.

This new position is to fill an unmet need in the Quality organization to support multiple, concurrent Marketing Authorization Application where In Country Testing by the Health Authority Central Labs.

EDUCATION

State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.

• Degree in a science field preferred
• Technical knowledge of Manufacturing, GMPs, QC, testing methods and pharmaceutical-related laws and regulations

EXPERIENCE

State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

• Previous experience working with or liaising with the Health Authority Central Labs testing is preferred
• Knowledge project management
• Knowledge of US and EU GMP and ICH guidelines
• 5+ years GMP experience years of practical work experience in the Biotechnology, Pharmaceutical or Medical Device industry in a similar role in Quality, manufacturing, and/or distribution organization.

Knowledge, Skills, and Functional Experience:

• Highly proficient in providing outstanding customer service, with a focus on achieving established timelines
• Functional knowledge of MS Office (Outlook, Excel, Word, etc.) and Windows operating system is required
• Strong attention to detail and agility to deal with emergent changing priorities on a day-to-day basis

Job-Specific Competencies

Leadership Skills:

• Gains cooperation and alignment with peers, managers, and individual contributors

Planning Skills:

• Ability to collaborate with the team to complete tasks, events, and internal customer requests
• Ability to plan daily responsibilities around emergent
• Self-motivated and detail-oriented with the ability to plan tasks and activities to achieve deadlines

Analytical Skills:

• Ability to work independently to troubleshoot problems and successfully resolve issues
• Identify, evaluate, and prioritize their tasks and activities as needed

Communication Skills:

• Ability to communicate with managers, peers, and internal BioMarin customers clearly and effectively, verbally and in writing

WORK ENVIRONMENT / PHYSICAL DEMANDS

Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.

Highly regulated pharmaceutical industry, fast pace interactions with internal and Health Authorities

EQUIPMENT

Describe any equipment required to perform the job.

Laptop

Access to internet

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