Quality Assurance Sr. Manager (Pharmaceutical, Biotech, Medical Devices)

Location: Remote
Department: Azzur Austin LLC

Job Description

Job Title: Quality Assurance Senior Manager

Department: Consulting Services

Division: Azzur Consulting

Location: Nationwide/Remote, preference for the East Coast

Working Hours: Core Hours

 

Summary Objective of position:

The Quality Assurance Senior Manager for Consulting Services is responsible for managing personnel and work for the master Quality Management System (QMS) documents delivered to clients, Client supplier audits (GLP, GCP, GMP), and high-level Quality Assurance Strategy and Task consulting.  Core responsibilities include service execution, client interactions and maintaining relationships, attracting and retaining personnel and project management. This position requires knowledge of pharmaceuticals, biopharmaceuticals, and medical devices as well as front-room experience with FDA EU/EMA inspections.

 

Client-related Responsibilities include:

          Authoring and reviewing master and client Quality Management System procedures, forms and templates

  • Knowledge of pharmaceutical, biopharmaceutical, and medical device regulations and standards, and hands-on experience supporting quality assurance, manufacturing, regulatory, clinical operations, and quality control
  • As a Quality Assurance Subject Master Expert
  • Pre-Approval Inspection Readiness and Regulatory Agency response client support
  • Supplier Audit Management and performing audits (GLP, GCP, and GMP)
  • Compliance consulting for GLPs, OECD guidance and ICH guidance, as well as QMS requirements for global regions.
  • Consulting work for Risk Analysis, CAPA and Deviation writing, Root Cause Investigations, and mentoring other consultants.

Some travel is required (approximately 20%)

 

Internal Services:

- Support the internal Quality Management System used for consulting

- Internal Azzur Group Clean Rooms on Demand Manufacturing auditing

- Internal Azzur Group Laboratory auditing

- Internal training

- Assisting with client complaints

- Financial reports support

 

The Quality Assurance Senior Manager is also a partially Billable Resource, as needed, in support of the Office’s financial goals and objectives, and a client’s Quality Assurance or project management work.

 

 

Essential Functions:

Percentage

A

Execute the tactical activities required to maintain revenue and profitability, manage business risks and implement the strategic direction such as assist and review financial report and client complaints

10%

B

Client Supplier Audits Management and conducting audits

40%

C

Oversee the master Quality Management System and Quality Assurance aspects of documents delivered to clients

25%

D

Quality Assurance Consulting (Pre-Approval Inspection Readiness and Regulatory Agency response client support, Risk Analysis, CAPA and Deviation writing, Root Cause Investigations, and mentoring other consultants.

15%

E

Internal Quality Management System and Training support

10%

Additional Functions:

  • Regularly interact with Management and/or customers
  • Interviews candidates and provides final recommendation to hire.
  • Partner with the sales organization to meet with new potential clients to build relationships for consulting work
  • Translate new and existing client needs into actionable value-added projects/results.
  • Prepare capability presentations, proposals, and agreements for new and existing clients for quality assurance work.
  • Monitor and report status of projects and key performance indicators, as needed.
  • Maintain resource levels and allocations to agreed upon utilization targets.
  • Responsible for timely review and approval of client and supplier invoices.
  • Collaborate with regional offices or functional areas on shared clients and needs.
  • Leverage and expand industry knowledge and contacts
  • Provide input and support marketing initiatives as needed.
  • Attend and/or present at industry conferences and publish articles.

 

Behavioral Requirements:

  • Embodies Azzur Group core values.
  • Introspective and accountable.
  • Self-motivated to produce results in a fast-paced, collaborative, and client-centric environment.
  • Able to effectively handle multiple responsibilities and job tasks (multi-tasking) and self-prioritize.
  • Demonstrated attention to detail and highly organized.
  • Flexible with work requirements, environment, and fast-paced/changing job needs.
  • Excellent written/verbal communication skills.
  • Capable of giving employees feedback and receiving coaching/feedback supporting individual success.

 

Promoting teamwork by:

  • Collaborating with co-workers.
  • Attending staff meetings as required.
  • Meeting individual company goals as established.
  • Establishing rapport and maintaining positive communication with others, demonstrating respect and support, cooperating and flexibility with change.
  • Adhering to company and department policies.

 

Supervisory responsibilities of direct reports:

-          Meets leadership goals by:

  • Planning, organizing and controlling all activities of the department in concert with the Leadership.
  • Supports Leadership by establishing and communicating goals for direct reports.
  • Coaching, developing and motivating direct report/s to maximize performance & potential.
  • Provides regular periodic performance feedback and follows the company’s commitment to conduct and issue introductory reviews and Quarterly reviews as required.
  • Monitor set goals on a regular basis (quarterly).

 

-          Meets Training & Development and HR goals, such as: 

  • Ensure adequate staffing levels are maintained.
  • Identify and attract new staff.
  • Participate in the training of new staff.
  • Provide mechanism for professional growth and development of staff.
  • Ensuring training has been received before undertaking specific duties and that all training is documented in training records as required by SOPs.
  • Conforming to Company's Policies and Procedures.
  • Ensuring accurate and timely completion of assigned employee timesheets.

 

General Requirements:

Maintains technical knowledge by attending educational workshops and/or reviewing publications.

Other duties as assigned by Sr. Management

Quality:

Adhere to all Standard Operating Procedures (SOPs) and Industry Regulations/Standards

Training & Development:

Ensure training has been received before undertaking specific duties and that all training is documented in training records.

Health & Safety:

Understand the company’s Health & Safety Policy and follow all associated procedures.  Report all accidents or awareness of any unsafe conditions in the workplace to management.

Human Resource Management:

Conform to the company’s policies contained in the Employee Handbook

Basic Qualifications & Position Requirements:

Required Education:

  • Minimum of an advanced degree in a scientific or technical discipline

Preferred Education:

  • Additional education, certifications, or masters degree in Engineering, Science, or equivalent degree

 

Required Work Experience: 

  • 10 years’ experience in pharmaceutical, biotechnology, or medical device industry

Preferred Experience:

  • 15 years’ experience in pharmaceutical, biotechnology, and medical device industries, including front-room Regulatory agencies inspections. As well as an ASQ CQA.

 

Required Knowledge:

          Knowledge of Quality Assurance tools and regulatory/standards documentation requirements

Preferred Knowledge:

  • Industry experience with GLP, GCP, GMP for pharmaceutical, biotechnology, and medical device

 

Skills (Inc. Typical Mental Demands):

Reasoning Ability/Mathematical Skills/Computer Skills/Language Skills:

  • Mathematical Skills
  • Computer Skills
  • Business acumen

 

Additional Qualifications:

          Flexible and able to work on several projects/clients

          Customer service/client relations

          Communication proficiency

          Attention to detail

          Can work productively independently with minor supervision

          Self-motivated, flexible, dependable and available

          Excellent organizational and time management skills

Work Environment & Dress attire:

 

Business casual in the office, business professional on client sites/during client visits and presentations and trade shows.

 

 



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