Vice President, Quality Assurance

4 weeks ago

Lakewood, United States Knipper Full time

Overview

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The Vice President of Quality Assurance is responsible for the strategic development and execution of Knipper Health's corporate quality assurance program and is accountable for the execution and administration of the QA & QC strategy, Quality Management Systems (QMS), and policies to assure compliance to FDA GxP regulations across products and all regulatory audit and inspection activities. This position is a strategic part of Knipper’s senior leadership team and will build and lead the team that will collaborate across our organization on global quality matters across three business units including Marketing and Samples Management (MSM), Custom Pharmacy Solutions (CPS), and 3PL Trade Distribution Services (3PL).

Hybrid role based out of Lakewood, NJ or Charlestown, Indiana corporate office.

Must be able to travel to other locations when necessary 20%.

Responsibilities

Ensures that the Quality System meets standards expected by US and global regulatory authorities for labeling, kitting, storage, distribution, and other commercial activities. Ensures quality metrics comply with best industry standards and practices. Maintains an effective Quality governance and continually improve governance to meet business and compliance needs. Ensures overall quality and compliance oversight for re-labeling, repackaging, supply chain, nonclinical and clinical. Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance. Establishes strong working relationships with external manufacturers of our products and assure alignment of our Quality Systems and requirements of Knipper clients and their customers. Establishes, maintains, and has oversight of internal Quality Management Systems. Continually establish and improve quality systems, initiatives, priorities, and time-lines. Ensures appropriate quality criteria built into selection, implementation or upgrading of electronic systems used to support any GxP-related activities. Provides leadership and mentor-ship of the Quality teams across all facilities and business units. Keeps abreast of industry developments, forthcoming regulations, guidance, best practices, etc. Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Leadership Team. Serve as an escalation point for corporate quality issues. Serves as primary contact in any audit by a regulatory authority and leads all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management.

The above duties are meant to be representative of the position and not all-inclusive.

Qualifications

MINIMUM JOB REQUIREMENTS :

Education/Training:

Bachelor, Master, or PhD degree in Engineering, Life Sciences, or similar fields related disciplines

Business Experience:

15+ years of relevant experience in GxP, QA leadership position in a Biotech/Pharmaceutical/ Medical Device industry, preferably in the area of supply chain and third-party logistics

KNOWLEDGE, SKILLS & ABILITIES :

Expert knowledge of current Good Manufacturing Practices including Good Documentation Practices, and Good Distribution Practices Extensive knowledge and in-depth experience of implementation of Quality regulations in supply chain services Familiar with ICHQ9 principles and has demonstrated the ability to utilize Quality Risk Management principles in everyday practice. Strong knowledge of US and other major global (ICH, EU) regulatory compliance requirements Extensive experience handling government regulatory inspection required. Strong collaborative, influencing and interpersonal skills with excellent verbal, written and presentation skills with the ability to deal effectively across all levels of management. A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members. Proficient in all elements of Microsoft Office

PHYSICAL DEMANDS:

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Knipper Health is an equal opportunity employer.

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