a. This position will provide quality leadership and technical support for Vaccine External Manufacturers (EM). Ensure the effective and compliant execution of
quality systems at the EM sites. Responsibilities include but not limited to review and approval of deviations, failure investigation, development of corrective action plans and monitor implementation. Review and approve EM quality system
documents, specification, and manufacturing instruction to ensure Janssen
products/process comply to cGMP and regulatory requirements. Provide QA
support for technology transfer and improvement of existing manufacturing
processes. Monitor quality performance of EM, proactive identification of risk and lead improvement program to mitigation EM risk.
b. This position will partner with EM in defining Quality Strategy and Supplier
Development Program through benchmarking and knowledge sharing (e.g.,
Account Plan, JJOs, SQE2 etc). Influence and build relationship with internal and external partners to continuously enhance quality culture and business excellence
(e.g., PEx, Lean etc.)
c. This position will lead work team to deliver business and quality goals with agility and patient focus. Responsibilities include mentoring, coaching, and training of team members to contribute to organization talent development.
a. Provide quality oversight to the selection, qualification, development, and
monitoring of EM
b. Monitor trends, identify quality issues, recommend, and implement appropriate actions.
c. Provide cGMP compliance support to EM by investigating and resolving quality issues.
d. Coordinate and provide concurrences on deviations.
e. Collaborate and support EM site during regulatory inspections. Monitor and follow up on EM regulatory response and commitments.
f. Author, revise, review and approve Quality System documents (SOP, WI etc.)
g. Investigate customer product quality complaints.
h. Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
i. Review and approve change control partnering with internal and external technical experts.
j. Lead EM risk management programs to maintain site qualification
k. Provide Quality oversight and participate on technology transfer and new product introduction teams
l. Support Regulatory Submissions activities.
m. Lead EM PAI readiness program in coordination with EM and Compliance, and project team
n. Maintain Quality Agreements and specifications changes
o. Drive continuous improvements and engineer quality into the process
p. Monitor trends, identify risk, troubleshoot, escalate to senior management as necessary.
q. Lead Escalation as defined in SOP, provide quality leadership in issue management and risk mitigation plan
r. Interface with other functions (Operations, Planning, Technical Operations, Local Affiliates etc) in the support of supply chain to meet patient supply requirements
s. Assess current quality systems and recommend improvements to enhance quality and cycle time
a. BS in Engineering, science, or equivalent technical discipline
b. 9 years working in an FDA regulated environment
c. Experience in managing operational quality oversight for vaccines DS and DP production
d. Experience interfacing with external partners
e. Experience managing tech transfers
f. Experience managing quality investigations and quality systems
g. Detailed knowledge of global health authority requirements for biologics and pharmaceutical production
h. Strong interpersonal and written/oral communication skills
i. Ability to quickly process complex information and make critical decisions with limited information
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!