Logo for US Tech Solutions

Principal Product Quality Leader #26-21313

US Tech Solutions

Role overview

Qualifications

  • Doctorate degree and 3 years of experience
  • Masters degree and 5 years of experience
  • Bachelors degree and 7 years of experience
  • Associates degree and 12 years of experience
  • High school diploma / GED and 14 years of experience

Responsibilities

  • Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs
  • Author and revise annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs
  • Conduct science and risk-based evaluation of complex process and product quality data
  • Communicate effectively with oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies

Key facts

  • Remote from: California (USA)
  • Fixed term
  • Expert & Leadership (>10 years)
  • Quality Manager
  • English

Hard skills

Other skills

  • Communication
  • Detail Oriented
  • Leadership
  • Teamwork
  • Problem Solving

About the company

US Tech Solutions logo

US Tech Solutions

Staffing & Recruiting

USTECH SOLUTIONS is the largest privately owned diversity workforce partner with a global footprint. For 20+ years, we have partnered with leading MSPs and some of the world’s largest enterprises to deliver a flexible workforce. We serve Fortune 500 giants and growing businesses alike, reinventing the role of humans in a digital workforce. ‘Reinventing Human’ is about connecting you with top talent and seamlessly integrating new hires into your programs through our next gen AI powered Talent platforms. As the largest private diversity supplier in the US, we champion inclusion and unlock hidden potential. We work with leading MSPs and are a trusted strategic partner to the world’s top brands. At USTECH SOLUTIONS, we're inverting the talent hiring pyramid by offering a range of solutions from curated talent pools, workforce management services, and IT services resourcing to IC compliance. Our legacy and close affinity to the computing industry has equipped us with the expertise and vision to provision AI platform solutions that help organizations to innovate faster. Considering Statement of Work? Meet US Tech Digital (ustechdigital.com). We're helping businesses achieve digital leadership through our tailored SOW solutions, utilizing market-leading technology products and our proprietary in-house developed platform solutions. Explore our full range of services and solutions by visiting our website: ustechsolutions.com

Company details

Company typeLarge
IndustryStaffing & Recruiting
Company size1001 - 5000

Links

Website LinkedIn See all jobs

Your match analysis

See how your profile stacks up against this role.

We compared the job requirements to your profile to show where you're strong and where you fall short.

Job description

Duration: 15 months contract
Shift: Standard Working Hours
 
Job Description:
  • Corporate Product Quality team is seeking an enthusiastic, highly motivated, and team-oriented leader for the position of Principal Product Quality Leader.
  • As Principal Product Quality Leader, you will provide technical expertise and leadership within a Product Quality Team.
  • You will engage with Product Quality, International Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other departments on a variety of activities. Such activities include product filings, program improvements, and investigations associated with product manufacturing, in-process controls, analytical methods, specifications, stability, reference standards, importation testing, change control, regulatory submissions and inspections.
  • You will support one or more of late-stage or commercial synthetic products and provide technical expertise and project support to the Product Quality Team(s) to develop, implement, and manage strategies to meet the Product Development Team goals.
  • You will be directly responsible for Product Quality related activities including ownership, authoring and review of GMP and regulatory documents, execution of transactions in relevant GMP systems (such as change control), and product data management including comparability assessments, annual product reviews, and product quality risk assessments. Your contributions will significantly improve initiatives intended to ensure the overall product health.
  • Offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to but are new to the industry as a whole. Help us to pave new roads for helping patients.
Primary Responsibilities include the following:
  • Provide effective, cross-functional quality leadership, and support program deliverables for late phase and commercial programs
  • Author and revise annual reviews, specifications, comparability, and stability programs; site and method transfers; product quality impact assessments; and author regulatory filing sections and RTQs
  • Conduct science and risk-based evaluation of complex process and product quality data
  • Communicate effectively with oral and written communication of complex information to Product Quality leadership, peers and regulatory agencies
  • Extract and analyze data from various sources and Quality systems
  • Demonstrate proficiency in knowledge of cGMP and international regulatory expectations 
Basic Qualifications:
  • Doctorate degree and 3 years of experience OR
  • Masters degree and 5 years of experience OR
  • Bachelors degree and 7 years of experience OR
  • Associates degree and 12 years of experience OR
  • High school diploma / GED and 14 years of experience
 
Top 3 Must Have Skill Sets:
  • Prior Biotech experience
  • Good communication skills
  • Attention to detail
  • Understanding of operations
  • Tactical in nature- able to receive tasks and work independently once trained (will be training period)
 
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"
 
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
IND01

#LI-AS140
 

Apply once. Then go straight to the hiring manager.

After you apply, unlock the direct contact details of the people who actually make the call. A quick follow-up makes you 5x more likely to land an interview.

MR

Marcus Rivera

Chief Revenue Officer

m.rivera@company.com
linkedin.com/in/marcusrivera
Unlocked after you apply
·

Quality Manager Related jobs

California (USA)

Other jobs at US Tech Solutions

Premium

Reach out to the hiring manager directly.

Gain access to the contact details of the hiring managers who actually decide, and reach out to network with them directly. That, plus more when you upgrade:

  • Full match report with fit score and gaps
  • Career diagnostics on how recruiters read you
  • Curated company matches and warm intros
  • 48h early access to new roles

Cancel anytime.