Director, QA Validation

B. Braun Medical Inc. (US); Irvine (CA); On-site; USD 178,000 - 255,000; Full time

Job summary

B. Braun Medical Inc. is seeking a Director of Quality Assurance to lead validation operations in healthcare product manufacturing. This role involves ensuring compliance with regulatory standards and improving validation processes across Pharma Franchise sites. Candidates should have over 15 years of experience in quality assurance, management capabilities, and relevant educational credentials.

Benefits

Healthcare Benefits

401(k) Plan

Tuition Reimbursement

Qualifications

• Requires Bachelor's degree, Master's preferred.
• 15 years related experience and 7 years management required.
• Industry/professional certification required.

Responsibilities

• Lead validation operations across Pharma Franchise sites.
• Oversee design of validation/qualification activities.
• Ensure regulatory compliance and validate procedures.

Skills

Management

Regulatory Compliance

Risk Assessment

Education

Bachelor's degree

Master's degree

Job description

6 days ago Be among the first 25 applicants

B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS.

Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.bbraunusa.com

Position Summary:

Responsibilities: Essential Duties

• Lead Pharma validation operations and staff across the Pharma Franchise sites.
• Lead and oversee the design of product, process and equipment validation/qualification activities.
• Assess Validation capabilities and procedures within the organization and propose strategies for improvements to help achieve both short term and long term corporate and sites objectives.
• Lead and manage the harmonization of validation procedures and process across the sites within the Pharma Franchise.
• Ensure adherence to regulatory requirements by overseeing the authoring, review and approval of all validation procedures and protocols/reports (IQ, OQ, PQs)
• Accountable for maintaining Validation Master Plans, Project Validation/Qualification plans, risk assessments, protocols, and reports to GMP standards.
• Identify potential risk associated with processes, equipment and product and collaborate with subject matter experts to implement mitigation strategies to minimize quality issues.
  
  

The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.

General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other person.

Expertise: Knowledge & Skills

• Requires breadth of professional field and industry knowledge. Ability to integrate critical information and champion advanced strategies/concepts through the organization. Drives development of advanced technologies, principles and processes.
• Manages activities of a functional area which has at least 2 departments or major functions through managers and/or experienced employees. Responsible for cost, method, and employee results.
• Judgement is required in resolving complex problems based on experience.
• Represents the organization as a prime contact on projects and departmental operations. Interacts with senior internal and external personnel on issues often requiring coordination across organizational lines.
  
  

Pay Range- $178,022 - $254,317

Expertise: Qualifications -Education/Experience/Training/Etc

Required:

• Bachelor's degree required, Master's degree preferred.
• 15 years related experience required, plus a minimum of 7 years management experience required
• Applicable industry/professional certification required.
• Regular and predictable attendance
• Occasional business travel required, cGMP experience/training required, Aseptic processing training/experience required
  
  

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.

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:

While performing the duties of this job, the employee is expected to:

• Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
  
  

Lifting, Carrying, Pushing, Pulling and Reaching:

• Occasionally:Reaching upward and downward, Push/pull, Stand
• Frequently:Sit
• Constantly:N/A
  
  

Activities:

• Occasionally:Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheral, Stooping/squatting, Walking
• Frequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Sitting , Talking - ordinary, loud/quick
• Constantly:N/A
  
  

Environmental Conditions:

• Occasionally:N/A
• Frequently:N/A
• Constantly:N/A
  
  

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.

• Noise Intensity:Moderate
• Occasionally: Other
• Frequently:N/A
• Constantly:Office environment
  
  

Equal Opportunity Employer Veterans/Disabled

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.

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.

We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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