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Quality Systems Manager in South San Francisco, CA at Apex Life Sciences

Date Posted: 11/28/2018

Job Snapshot

Job Description


POSITION SUMMARY:

The primary responsibility for this position will be establishing and managing the Quality Systems and GXP compliance activities with a focus on continual improvement. This is a key quality management role reporting to the Executive Director of Quality Assurance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

Responsibilities of the Manager will include, but are not limited to:

  • Managing and administrating the internal and external Quality systems including CAPA, deviation, change control, OOS, Product complaints, and Training. Write and review SOPs as needed
  • Providing leadership to and managing the daily activities of the QA Systems and Compliance (GMPs, Part 11).
  • Assessing and approving quality system documentation including implementing and coordinating all activities relating to the control, distribution, maintenance and closure of GMP Quality documentation
  • Demonstrating leadership by ensuring the continual improvement of the Quality Systems.
  • Ensuring management of changes associated with products and processes are carried out appropriately using science and risk-based assessment to determine the impact of change.
  • Providing leadership to and managing the Internal and External Audit programs.
  • Identifying compliance risks and developing sound rationale as basis for the observations.
  • Support generation of Annual Product Reviews in compliance with the requirement of GMP and Regulations.
  • Coordinating activities and supporting interactions during regulatory agency inspections and customer audits.
  • Ensuring key performance indicators measure progress against quality objectives.
  • Monitoring, communicating and acting on any emerging trends.
  • Analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
  • Mentor personnel in the QA organization as requested by the Head of QA & Compliance.
  • Supervise the Document control position
  • Support Quality Operations as needed
  • Support other GXP activities as needed

KNOWLEDGE AND SKILL REQUIREMENTS:  

  • Bachelor’s degree in a scientific discipline.
  • Minimum of 5-7 years experience in a Quality Assurance role in the pharmaceutical industry.
  • Supervisory experience of at least 1 year preferred.
  • Independent decision making with a high degree of initiative.
  • Specialized knowledge of QA Systems and Compliance, business principles and departmental processes.
  • Ability to work on complex problems in which analysis of situations or data.
  • Effectively interacts with internal peers and site management to lead continuous improvement.
  • Extensive knowledge of US/EMA GMP requirements and associated guidelines.
  • Experience in implementation and administration of quality systems for drug product development, clinical and commercial manufacturing and quality control operations.
  • Experience in Pharmaceutical Quality Assurance, including the ability to identify and resolve compliance issues.
  • Experience in participating in pharmaceutical technology transfer teams.
  • Experience in the qualification of facilities, utilities, equipment and processes.
  • Ability to increase others knowledge of GMP regulations and guidance.
  • Strong written and oral communication skills.

PERSONAL ATTRIBUTES:

  • Uncompromisingly committed to quality
  • Motivated self-starter; detail- and results-oriented
  • Well organized and efficient worker with good communication skills
  • Innovative thinker and problem solver
  • Flexible; able to embrace change
  • Ability to manage multiple duties and tasks
  • Ability to utilize knowledge and interpersonal skills to provide leadership, direction and development of others, both within the department and cross-functionally.

WORKING CONDITIONS:  

  • PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear.  Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. 

  • WORK ENVIRONMENT:  The noise level in the work environment is usually moderate.  10 to 20% travel is required.



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