Internal Operations Manager (REMOTE)

Azzur’s Objective with this Position:

The Manager of Internal Operations is responsible for the management and continuous improvement of Azzur Group Consulting’s Quality Management System (QMS) policies, procedures and activities, and reporting on performance to predefined Quality Metrics. In addition, this person is also responsible for the capture and management of the technical knowledge gained by Azzur Group’s consultants as part of client Service Execution. The primary focus areas for QMS include Internal Training, Supplier Qualification, and Customer Issues & Complaints. Also, this person will lead teams responsible for either responding to customer assessment requests or performing internal auditing of Azzur Group Consulting. 

 
Essential Duties and Responsibilities:

• Internal Consultant Training: Responsible for establishing the training curriculums for each position (C0-C5) and employment type (e.g., FTE, W2, C2C) within Azzur Group’s Consulting division and ensuring workforce compliance.
• Supplier Qualification: Responsible for defining the requirements for Azzur Group Consulting suppliers to be qualified and approved for use, actively managing the Approved Supplier List (ASL), and interacting with suppliers.  This may include software validation.  Supplier Types include but aren’t limited to 3^rd Part Calibration Labs, Software and Equipment Suppliers.
• Customer Issues & Complaints: Responsible for supporting the receipt, recording, response, and resolution of issues & complaints received by the individual Consulting Offices.
• Quality Management System and Quality Metrics: Responsible for management and continuous improvement of Azzur Group Consulting’s Policies & Procedures and reporting on the Quality System performance metrics to Divisional Leadership on a Monthly basis, and to Azzur Group Sr. Leadership on a Quarterly basis.
• Service Execution: Responsible for partnering with the individual consulting Offices to capture knowledge gained during service execution and actively managing its availability for sharing/trainings and leverage during future engagements.

Additional Responsibilities:

• Interact with clients and respond to clients on Client QA Questionnaires in a timely manner.
• Working knowledge of maintaining compliant quality systems in pharmaceutical, biotechnology, and medical device industry. pharmaceutical, biotechnology, and medical device industry.
• Understanding of supplier qualification management, supplier/vendor management, and supplier lifecycle within the pharmaceutical and biotechnology industry, including maintenance of questionnaires, audits, QTAs, and validations to current revisions.
• Knowledge of CAPA, Deviation, Change Control maintenance within a GMP environment.
• Familiar with organizational Knowledge Management systems principles per ISO 30401:2018
• Advanced knowledge of project management tools, Microsoft office.
• Facilitate practice leader meetings, committee meetings, and functional meetings as needed

• Note: this position is expected to be remote with occasional on-site meetings and trainings.

Ideal Behavioral Qualities:

• Handling multiple responsibilities and job tasks (multi-tasking) as needed.
• Demonstrating strong attention to detail.
• Flexibility with work requirements, work environment and fast-paced/changing job needs.
• Strong verbal and written Communication skills
• Able to critically think and translate traditional operating company GMP requirements for Quality System to requirements that apply to a professional services organization.
• Able to build relationships with the practice leaders of each consulting office and effectively partner with them to meet quality requirements and service execution goals.

Minimum Required Education and Experience:

• Bachelor's Degree in Engineering, Science, or equivalent degree.
• 4-10 years’ experience in a regulated environment within the biotechnology, pharmaceutical or medical device industry or requisite equivalent experience.

About Azzur

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.

No matter where you are in the product development lifecycle, Azzur is here to help you start, scale, and sustain your business. From pre-clinical manufacturing to process design and process performance qualification, Azzur Group works hand-in-hand with the world's most renowned manufactures to employ risk-based and phase appropriate GxP solutions.

With a national network of engineers and consultants, we offer comprehensive quality assurance and regulatory compliance, and validation services specifically geared for the complexities of life science.

Do What You Love

We are seeking highly motivated individuals that have the desire to learn, are able to adapt to the ever-changing life sciences field and are flexible to work on various projects throughout the Southern California region all while exuding Azzur’s core values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

We aim to serve our clients, create a healthy and fun work environment, and assist with professional growth for each individual through customized career development plans. As a consultant working on multiple cross functional projects, you will be able to quickly garner a wide range of skills and areas of expertise that will propel your career progression.

If a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you!

 Perks of Working at Azzur:

• Medical, Dental and Vision
• Competitive 401K plan
• Flexible Paid Vacation Time
• Employee Recognition Program
• Diversity and Inclusion Initiatives
• Training and Mentorship Opportunities

Learn more about who we are and what makes us great here: https://www.youtube.com/watch?v=9VmKkBLkoFQ