Job Purpose: Provide regulatory compliance expertise on quality systems for manufacturing and distribution of pharmaceuticals, medical devices and active medical devices, as well as compounding admixture pharmacies processes and related products. Ensure internal B. Braun compliance to applicable regulations and standards (FDA Drug/Medical Device regulations, ISO Standards, Medical Device Directives (MDD), Canadian Medical Device Regulations (CMDR), USP 797 and other applicable regulatory requirements), and the B. Braun quality systems and of B. Braun suppliers through periodic auditing. Establish guidelines and requirements from Quality Assurance perspective in supporting special projects.
Responsibilities: Essential Duties
- Perform internal audits of B. Braun US facilities in accordance with audit schedule. This includes establishing audit agenda, scheduling audit, executing audit, issuance of audit reports, and verifying corrective actions to resolve any identified nonconformities.
- Perform external supplier assessments for the manufacturing, contract laboratories and services areas.
- Provide support to global B. Braun affiliate companies on US FDA compliance matters, as required.
- Support the company audit program (internal, supplier, customer and regulatory) to ensure timely and effective corrective actions are developed, implemented and verified to resolve audit observations while maintaining compliance with applicable FDA Quality System Regulations and ISO standards.
- Stay abreast of evolving regulatory trends and expectations that are relevant and ensure that appropriate action is initiated to maintain company compliance. Communicate these trends to applicable personnel.
- Collaborate with Quality Assurance and Operations in the development of corrective actions, review and verification of responses to regulatory agency findings and/or OEM customer observations.
- Provide guidance and regulatory advice during the development, implementation and effectiveness verification of the corrective/preventive actions according to the established procedures and corrective/preventive action plans.
- Develop and report on audit and compliance metrics for all B. Braun US operating facilities Escalate compliance risks to Quality Management,
- Participate in the development and execution of quality/regulatory-related training and education
- Identify and recommend quality system improvements when gaps are identified through audits, gap analysis and quality system management reviews.
- Provide support in collaboration with Manufacturing and Quality for the investigation and root cause analysis of product, process and quality systems gaps.
- Provide support and assist with coordinating activities related to recalls.
- Work interactively with cross-functional teams to achieve company business and quality goals/objectives.
- Ensure operations within approved department budget.
- May represent the organization in outside discussions and technical forums related to FDA or Notified Body initiatives.
- Informatics & Analytics
- Inspection Readiness
Expertise: Qualifications – Experience/Training/Education/Etc
- Eight (8) or more years in professional experience.
- Bachelor’s Degree in technical or scientific discipline. Master’s Degree preferred.
- Experience in performing and hosting internal audits, supplier audits, FDA/ISO regulatory inspections
- Experience with cGMP’s, and FDA guidelines
- Certified Quality Auditor (CQA), RABQSA or Quality System Lead Auditing Certification by an accredited nationally recognized organization is strongly preferred.
Expertise: Knowledge & Skill Requirements
Strong working knowledge of Pharmaceutical (21 CFR 210 & 211) and Medical Device Quality System Regulations (21 CFR 820), ISO 13485, ISO 9001, ISO 17025 and Medical Device Directive (MDD) requirements.
- Good working knowledge of ISO, CE, UL, CSA, and USP requirements
- Excellent computer and PC skills including experience with MS Office applications, database and statistical applications
- Word Processing, Statistical and Database applications.
- 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.
- The ability to comprehend and interpret regulatory laws, standards and guidelines (i.e. ISO, EN, MDD QSR/cGMP’s, GHTF, ICH, CFR’s, IEC).
- Excellent oral and written skills.
- Strong interpersonal skills.
- Has well-developed leadership qualities.
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.
- 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.
- Valid driver license and current passport required
- Able to travel approximately 25% per calendar year to domestic and international destinations
- Resume’s may be sent to Mai.Evans@BBraun.com or www.bbraunusa.com/careers.
- B. Braun is located @ 901 Marcon, Blvd. Allentown, PA.
B. Braun Medical Inc. (B.Braun) is part of a global organization with more than 44,000 professionals.
Our far-reaching family of companies includes over 50 locations worldwide, including manufacturing, marketing and sales firms in Asia, Europe, North America, the Pacific Rim and South America. We offer a positive work environment, competitive salary, benefit packages and a Sharing Expertise® culture that rewards performance.
B.Braun USA has been recognized as one of the top 25 “Best Places to Work” by Medical Device and Diagnostic Industry (MDDI) magazine.