Head of Quality Systems

Location
San Francisco, CA, United States
Posted
Nov 11, 2020
Ref
933
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
HEAD OF QUALITY SYSTEMS

Position Summary:

The Head of Quality Systems is a leadership position within the Global Blood Therapeutics' (GBT) Operations team with the responsibility to ensure that the requirements of the pharmaceutical Quality Management System (QMS) are effectively established and maintained for Development and Operations. The Head of and Quality Systems is responsible to ensure compliance in both a development and commercial environment and is responsible for the continuous improvement of the QMS by prioritizing key performance and capability gaps for remediation, leading key initiatives, managing a portfolio of improvement projects, and owning the management of digital solutions used to develop the organizational capability of the QMS. This position will also be responsible for reporting on performance to management with executive responsibility for review.

The Head of and Quality Systems collaborates with the organization to assure that all functions are provided appropriate tools to facilitate compliance with ICH Q8, Q9 and Q10, 21 CFR parts 11, 210 and 211, 610, and EU Guidelines to GMP, ensuring systems and tools that support compliance are implemented, assessed, and maintained by establishing operational objectives, executing company policies, and recommending policy changes. Head of, Quality Systems will manage, develop, and appropriately resource the quality systems function.

This position will work on complex problems in which analysis of situations or data requires an in-depth evaluation of compliance and operational risk. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria and leverages the talent of the organization for obtaining results. Ensures budgets, schedules and performance requirements are met.

Essential Duties and Responsibilities:

Accountable for the effectiveness of the Quality Systems and development of operational strategies supporting the continuous improvement of:
  • Risk Management: Develops program and policy, drives implementation and effectiveness reviews
  • Data Integrity and eSystems compliance: Develops program and policy, drives implementation including electronic GxP solutions, where applicable and provides Quality oversight
  • Document Control, Business Process and Document Management
  • Training, including GxP training for corporate personnel
  • Change Control
  • Deviations (investigations, corrective and preventative actions)
  • Quality Management Review
  • Product/Customer Complaints
  • Regulatory and internal/external audit Inspection Management
  • Governance / Operations Reviews: Design, deploy and facilitate leadership meetings - including strategy sessions that incorporate key partners
  • Business Operations and Performance Management: Develop and report on Key Process Indicators (KPIs)
  • Manage Inspections during regulatory inspections with inspection logistics oversight
  • Vendor Management
  • Represent Quality Assurance on cross functional teams as appropriate
  • Provide QA expertise, advice, or assistance to other departments as required
  • Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork
  • Development of the capabilities and maturity of the quality systems function

Qualifications:
  • A BS, MS, or PhD in a scientific related field and a minimum of 10 years pharmaceutical industry in a Quality function
  • In-depth knowledge and experience implementing phase appropriate quality systems to achieve GxP compliance
  • Strong and clear understanding of cGMPs,and quality systems best quality practices
  • Demonstrated leadership in cross-functional and culturally diverse team settings
  • Excellent interpersonal skills with the ability to influence individual and teams across the organization in the absence of a direct reporting relationship
  • Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
  • High energy, enthusiasm and excellent leadership and management skills
  • Excellent verbal, written, interpersonal, organizational, and communication skills are necessary
  • Drive, desire, motivation
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
  • Comfortable executing on multiple projects independently

Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.