Associate Director, Quality Assurance GCP
Company: Kaztronix
Location: San Diego
Posted on: May 26, 2023
|
|
|
Job Description:
Position Summary:
The Associate Director, Quality Assurance GCP is responsible for
actively supporting the implementation of GCP initiatives and for
leading the execution of clinical quality related activities. -
This position will lead Inspection Readiness Activities, assist
with the management of the audit program, and partner with key
clinical and cross-functional groups (e.g., Clinical Compliance,
Clinical Operations, Biometrics, Regulatory Affairs) to ensure
compliance of Clinical Development Programs and continuous process
improvement.
Responsibilities:
Develop and implement Quality Programs where needed.
- Develop and implement risk based GCP audit strategies across
clinical programs and/or studies.
- Manage and/or actively support the development, enhancement,
review, and implementation of GCP quality standards and controlled
documents (e.g., SOPs, Work Instructions, Templates)
- Promote compliance and quality throughout the company and
represent the Quality Department in internal meetings and
events.
- Build, develop and maintain working relationships with internal
and external partners.
- Provide input and expertise to clinical vendor risk assessments
in support of the Clinical Vendor/Service Provider Qualification
Program.
- Plan, conduct and manage audits of clinical vendors, clinical
sites, and/or internal clinical processes, and associated follow-up
activities (e.g., reports, corrective actions). -For those audits
conducted by external auditors, lead coordination and communication
activities between internal stakeholders and auditors to ensure
audits fulfill business needs.
- Partner with Clinical Compliance and other internal stakeholders
to manage clinical vendor and/or clinical site oversight and/or
issue management. -
- Conduct and/or facilitate investigations of GCP Quality Events
and collaborate with subject matter experts to conduct root cause
analysis and to develop corrective and preventive action plans, as
applicable.
- Partner with Clinical Compliance in the management of the
inspection readiness program and regulatory inspection management
while providing input to inspection-related process improvement. -
This may include:
o Project Management activities for Inspection Readiness
initiatives. -
o Complete Inspection Readiness activities including preparing
internal teams, clinical sites and significant clinical service
providers. -
o Lead cross-functional team to ensure a state of "constant"
inspection readiness.
- Partner with Clinical Compliance for the implementation and
management of Clinical Risk Management Program
- Lead or contribute to the development and maintenance of key
Clinical Quality Metrics for input into process improvement
initiatives and/or presentation to Study Management Teams and
Senior Leadership.
- Lead the development and delivery of clinical quality and
compliance related training to internal functions. - This may
include coordination efforts in training events delivered by
Clinical Compliance and/or external consultants.
- Provide GCP guidance to internal stakeholders or Study Management
Teams, as applicable.
- Participate in quality and/or cross-functional process
improvement initiatives, as applicable.
- Other duties as assigned by Quality Assurance Management.
Education/Experience Requirements: -
- Bachelor's degree in related Life Sciences discipline is
required; advanced degree preferred. Equivalent combination of
education and applicable job experience may be considered.
- 8+ years in drug/biologics development in the biotechnology or
pharmaceutical industry. -
- 7 years previous GCP Quality Assurance experience in Clinical
Research and Development and/or GLP auditing is preferred. -
- Experience leading, developing and/or implementing Inspection
Readiness Programs and associated activities. -Experience in
managing inspection and post-inspection follow-up activities.
- Minimum of 5 years of Quality Assurance auditing experience is
required.
Additional Skills/Experience: -
- The ideal candidate will embody core values: Courage, Community
Spirit, Patient Focus and Teamwork.
- In-depth knowledge of and ability to interpret and apply GCP EU,
FDA and ICH regulations and guidelines.
- Strong working knowledge/experience in planning, conducting, and
reporting clinical site and service provider audits.
- SQA RQAP registration a plus.
- Experience with Microsoft based applications and ability to learn
internal applications/systems.
- Experience with eQMS systems is a plus.
- Ability to identify quality issues/discrepancies, and effectively
and proactively manage, and resolve the issues/discrepancies in a
diplomatic, flexible and constructive manner.
- Well organized with the ability to multitask, prioritize and
manage shifting responsibilities in a dynamic, cross-functional
teamwork environment.
- Excellent collaboration skills with strong attention to detail
and the ability to multi-task and manage complexity.
- Strong interpersonal and organizational skills and excellent
verbal and written communication skills are required.
- Ability to travel 10-30% domestically and internationally. -
Kaztronix is an equal opportunity employer and does not
discriminate on the basis of race, color, national origin, sex,
age, religion, disability, veteran status or any other
consideration made unlawful by federal, state or local laws.In
addition, all human resource actions in such areas as compensation,
employee benefits, transfers, layoffs, training and development are
to be administered objectively, without regard to race, color,
religion, age, sex, national origin, disability, veteran status or
any other consideration made unlawful by federal, state or local
laws.
Keywords: Kaztronix, San Diego , Associate Director, Quality Assurance GCP, Executive , San Diego, California
|
Click
here to apply!
|
