Director, Quality CAPS - B. Braun Medical Inc.

Overview:

CAPS®, the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation’s largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS is part of the B. Braun Group of Companies in the U.S.

 

Responsibilities:

 

Position Summary:

Plan, organize and direct the activities related to the CAPS Quality function to ensure timely completion of the group tasks. The CAPS Director, Quality is also responsible for the development and implementation of related programs to maximize efficiencies of staff, testing and budgetary resources necessary to suppose the company goals while complying with regulatory requirements.

Responsibilities: Essential Duties

• Oversees the performance of functional group to assure that products and processes meet company and regulatory requirements.
• Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality consistent with department and company operating objectives.
• Provide technical assistance and direction to the other functional groups. Interface with regulatory agencies during routine audits, field complaint investigations, and technical interchanges to present the company's view point.
• Develop, direct and implement validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements.
• Supervises the implementation of internal audit program to determine any deficiencies in the Admixing / Compounding Pharmacy Operations as they relate to current regulations.
• Directs the investigation of excursions in Admixing / Compounding Pharmacy or other related operations resulting in abnormal operation rejections. Resolves nature of the cause, impact, disposition and corrective actions.
• Ensures the efficient use of resources in order to achieve department quality and operation plan objectives.
• Provides supervision to CAPS Quality Control Coordinators.
•  

Expertise: Knowledge & Skills

• Broad knowledge of scientific theories, instrumentation and techniques
• Thorough knowledge of GMPs, GLPs and pharmaceutical products.
• Familiar with the USP, FDA, Aseptic Process, and other regulatory guidelines
• Working knowledge of all phases of company and laboratory operations

 

 

 

The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case.  The range provided is a reasonable estimate.

 

#ID

#LI

#SL

Target Based Range:119,006.00 - 154,706.00Qualifications:

Expertise: Qualifications - Experience/Training/Education/Etc

Required:

• B.A./B.S. degree in related science
• 10 or more years of experience in an admixing, pharmaceutical, or medical device company.
• Minimum of 5 years previous managerial experience
• Frequent travel required
• cGMP training/experience required.
• Aseptic processing training/experience desired.  Training will be provided.

Desired:

• Advanced degree

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.

 

Additional Information:

Responsibilities: Other Duties:

• Business travel, Driver’s License.

 The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.

 Physical Demands:

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms.  The employee is occasionally required to stand and walk.  The employee must occasionally lift and/or move up to 20 pounds.

 Work Environment:

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually moderate. 
• Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.

What We Offer :B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com. Through its “Sharing Expertise®” initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.Notices:

Equal Opportunity Employer Veterans/Disabled