B. Braun

Manager, Regulatory Compliance CAPS

Job Locations US
Requisition ID
2022-22209
Company
Central Admixture Pharmacy Services, Inc.
# of Openings
1
Category
Quality
Position Type
Regular Full-Time
Shift
Mon - Fri - 8:00 am - 5:00 pm
Site
CAPS

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:

 

Provide quality and regulatory compliance expertise for quality systems and product quality for pharmaceutical compounding processes and related compounded sterile preparations (CSPs) within CAPS. Oversee internal site compliance to applicable regulations, standards and quality systems and through direct interactions across all functional lines and periodic auditing. Establish guidelines and requirements for quality and regulatory compliance in supporting special projects and ongoing operations.

 

Responsibilities: Essential Duties

  • Serves as a quality and regulatory compliance expert to the CAPS Operations. Maintains comprehensive knowledge of applicable quality and regulatory requirements and their interpretation. 
  • Assist in the development and support of the company audit program (internal, supplier, customer and regulatory) to ensure timely and effective corrective/preventative actions are developed, implemented and verified to resolve audit observations, while maintaining compliance with applicable FDA Quality System Regulations, USP Regulations, industry standards and meeting/exceeding current industry practices. Serve as the key leader within CAPS to establish, implement and maintain audit readiness program.
  • Develop, review and verify responses to regulatory agency findings or internal and/or customer observations.
  • Support Operations to develop requirements for external supplier qualification and ongoing assessments for the manufacturing, laboratories and services areas.
  • Provide guidance and regulatory advice during the development, implementation and effectiveness verification of the corrective/preventive actions according to the established procedures and established action plans.
  • Host/support external audits, compliance inquiries and/or surveys.
  • Develop, track, trend and report to management on compliance metrics. Identify, communicate and escalate to Executive Management, as required, compliance issues and risks for further comprehensive action.
  • Participate in the development and execution of quality/regulatory-related training and education.
  • Provide support in collaboration with Pharmacy and Quality Operations for the investigation and root cause analysis of product, process and quality systems gaps, deviations and discrepancies.
  • Provide support for product impact assessments when gaps, deviations and non-conformances in product, processes and quality systems are identified; and provide recommendation of appropriate actions
  • Work interactively with cross-functional teams to achieve company business and quality goals/objectives.
  • Stay abreast of evolving regulatory and industry standards trends that are relevant, and ensure that appropriate action is initiated and communicate these trends to applicable personnel.
  • Ensure compliance to applicable regulations and standards
  • Responsible to hire, develop, promote and discipline regulatory compliance personnel.

Expertise: Knowledge & Skill Requirements

  • Good working knowledge of Pharmaceutical (USP <797>, 21 CFR 210 & 211, and 503B, and USP <797>) and Medical Device (21 CFR 820) Quality System Regulations
  • Good working knowledge of USP, FDA, ISO and ICH requirements
  • Excellent computer and PC skills including experience with MS Office applications, database and statistical applications
  • Sufficient human relations and leadership skills to effectively staff and manage relevant personnel, including external consultants, and functions to assure that company goals and responsibilities are met.
  • Ability to act effectively as a member of a team to resolve problems.
  • Ability to simultaneously work on several projects with the flexibility to reprioritize in a minimum amount of time.
  • Ability to investigate and analyze technical and regulatory issues.
  • Excellent oral and written skills.
  • Strong interpersonal skills.

Additional Requirements:

  • Valid driver license and current passport required
  • Able to travel ≥ 25% per calendar year

Target Based Range

$101,840 - $127,300

Qualifications

Expertise: Qualifications - Experience/Training/Education/Etc

 

Required:

  • BS degree in technical or scientific discipline and eight or more years of related experience preferably in the pharmaceutical or medical device industry.
  • Experience in auditing for performing and hosting internal audits, supplier audits, 3rd party audits, Board of Pharmacy/FDA/ISO regulatory inspections.
  • Experience with USP, cGMP’s, and FDA guidelines.
  • 5 or more years Management experience

 

Desired:

  • Certified Quality Auditor (CQA) Preferred
  • Experience with State Board of Pharmacy
  • MS or PhD in a related science

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.

 

 

 

 

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Additional Information

Responsibilities: Other Duties:

 

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:

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

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.

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

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