BocaRatonRecruiter Since 2001
the smart solution for Boca Raton jobs

Senior Director, Regulatory Affairs & Lab Operations

Company: CSL Plasma Inc.
Location: Boca Raton
Posted on: September 12, 2020

Job Description:

Senior Director, Regulatory Affairs & Lab Operations With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring  is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma  , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

GENERAL SUMMARY

This position is responsible for leading and directing strategy for regulatory compliance for all CSL Plasma Inc. (CPI) operations, in the US and Europe.

Authorized Official for contact with FDA

Serve as liaison/representative for company’s submission to regulatory agencies

Collaborate with Regulatory Affairs efforts within the CSL Plasma Group and CSL Corporate to ensure regulatory requirements and the impact provide clear direction for the organization

Lead and direct strategy for laboratory operations located I Knoxville, TN/US and Gottingen Laboratory in Germany

RESPONSIBILITIES

Represent CPI as an Authorized Official or responsible person in interactions with regulatory agencies worldwide. Directly interface with regulatory authorities as needed on issues. Maintain a positive relationship with all regulatory officcalls and respond to all inquiries in a timely fashion. Accompany and negotiate with European and other foreign health authorities during Center and laboratory audits, and conslult with FDA inspectors as needed. Serve as liaison/represnetative for company’s submissions (BLA, PAS, CBE) to regulatory agencies.

Lead the development of strategic and tactical objectives, plans and programs for Regulatory Affairs and CPI Laboratories that will position CPI as the industry leader in these areas. Advise senior management concerning regulatory requirements and the impact on project status and company compliance. Participate with new development teams to identify and evaluate new business opportunities.

Responsible for the direction and leadership to the CPI Knoxville and Gottingen laboratories to ensure efficient and effective operations to deliver testing that meets the needs of CSL.

Direct the definition and implementation of the regulatory strategy and policy for CPI, in order to meet company objectives and to ensure product manufacturing and development plans are scientifically sound and comply with federal, state and international regulatory authorities, and customer specifications in all CPI facilities.

Provides consultation to other CPI departments for the development and implementation of business processes that impact regulatory compliance.

Senior Director (or delegate) review and approve of all Standard Operating Procedures (SOPs), including revisions to SOPs, procedures and training materials ensuring they comply with all governing agencies.

Ensures that regulatory policies and procedures are written and implemented in accordance with all applicable international (GHA), federal (FDA, CLIA, OSHA), state, local and industry (ISO, QPP) regulations and requirements.

Directly responsible for the development and improvement of programs, policies and procedures that meet or exceed the requirements of all regulatory bodies and are designed and implemented to assure maximum efficiency and meet or exceed the expectations of all stakeholders.

Maintain current knowledge of regulations, review laws and the Federal Register, and attend seminars and FDA hearings maintaining specific knowledge/licensure or certification a requirement of this position for Labs or organization in general. Maintain current knowledge of regulations.

Maintain clean efficient work environment and ensure sufficient operating supplies and forms are available. Comply with all Health, Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedures and documentation audits, as applicable. Promote safety in all actions.

Manage staff, including selection, training, development, coaching and termination. Appraise employee performance and provide feedback and counseling to staff, when necessary. Develop succession plans and oversee career development of immediate staff. Develop and manage to annual budgets designed to meet or exceed objectives by continuous review of performance against KPIs.

JOB SPECIFICATIONS

Education

Bachelor’s degree required

Doctoral degree in Biological Sciences or related health sciences preferred

Experience

15+ years of progressively responsible experience in an FDA regulated industry, or with the FDA, including some lab and GMP experience

Direct supervisory experience (both professional staff and line personnel)

Project management experience

Additional Comments

Strong technical background, familiarity with cGMP, FDA, CLIA, OSHA and EU regulations related to Biologics and pharmaceutical manufacturing

Working Conditions

Understands opposing points of view on highly complex issues and negotiates different viewpoints

Ability to make decisions which have significant impact on the immediate work unit and monitor impact outside immediate work unit

Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact, etc. and/or to make formal presentations

Occasionally exposed to hazardous chemicals, extreme temperatures and to blood borne pathogens

Overnight travel required up to 30% of the time

Fast paced environment with frequent interruptions

#CB

Worker Type:

Employee Worker Sub Type:

Executive

Posted 16 Days Ago

Full time

R-118326

About Us With operations in 35+ nations and ~ 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring  is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma  , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

If you are an individual with a disability and need a reasonable accommodation for any part of the

CSL does not accept referrals from employment businesses and/or employment agencies with respect to the vacancies posted on this site. All employment businesses/agencies are required to contact CSL's human resources department to obtain prior written authorization before referring any candidates to CSL. The obtaining of prior written authorization from the human resources department is a condition precedent to any agreement (verbal or written) between the employment business/ agency and CSL. In the absence of such written authorization being obtained, any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of CSL. CSL shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Keywords: CSL Plasma Inc., Boca Raton , Senior Director, Regulatory Affairs & Lab Operations, Other , Boca Raton, Florida

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


High Demand For Quality Remodelers - Get New Clients In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Fort Pierce
Posted on: 09/21/2020

Executive Director
Description: Sunrise Senior Living is an Equal Opportunity Employer. Executive Director in Boynton Beach, Florida Careers at Sunrise of Boynton Beach Skip to Main Content Please Enable Cookies to Continue Please (more...)
Company: Sunrise Senior Living
Location: Boynton Beach
Posted on: 09/21/2020

Appointment Setting Entry Level
Description: We are currently seeking work from home customer service, appointment setting, telemarketing and data entry representatives. You're main responsibility is to supply specialized guidance to our current (more...)
Company: Tima
Location: Delray Beach
Posted on: 09/21/2020


Project Superintendent
Description: Job Details Full-timeEstimated: 41,000 - 53,000 a year3
Company: Seagate Construction Group
Location: Delray Beach
Posted on: 09/21/2020

Hair Stylist - Waterways of Parkland
Description: Stylist At Great Clips, we know that stylists like you are most happy when they''re cutting hair, so at a Great Clips salon, that''s exactly what you get to do Want to be the best stylist
Company: Great Clips
Location: Delray Beach
Posted on: 09/21/2020

Private Investigator
Description: Statewide agency with over 35 years of service seeks experienced investigator for surveillance in Manatee and Sarasota County area. Our highly trained investigative
Company: Identifax
Location: Lehigh Acres
Posted on: 09/21/2020

Full Time Entry Level Immediate Hire
Description: We are currently seeking work from home customer service, appointment setting, telemarketing and data entry representatives. You're main responsibility is to supply specialized guidance to our current (more...)
Company: Tima
Location: Jupiter
Posted on: 09/21/2020

Installation Subcontractor
Description: Job DescriptionLeafFilter Gutter Protection Installers needed for immediate work as independent contractors. We provide in-depth knowledge so you can correctly and efficiently install our gutter protection (more...)
Company: LeafFilter
Location: Boynton Beach
Posted on: 09/21/2020

92G Food Service Specialist
Description: Job Description It takes energy to keep the Army National Guard marching on, and that s where you take the lead. As a Food Service Specialist for the Guard, it s your duty to provide the sustenance (more...)
Company: National Guard
Location: Homestead
Posted on: 09/21/2020

Delivery Driver (Part Or Full Time) With Doordash - Make Up To $16/Hour
Description: No passengers. No bosses. Just you, your tunes, and the road. Sign up now and start making money Choose your wheels and deliver food and other items from local merchants to
Company: Doordash
Location: Lehigh Acres
Posted on: 09/21/2020

Log In or Create An Account

Get the latest Florida jobs by following @recnetFL on Twitter!

Boca Raton RSS job feeds