Pinnacle 21 | Quality Assurance Manager - Technical.ly

Quality Assurance Manager

Pinnacle 21 |  Blue Bell, PA | Ops / PM

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Job Description
Perks + Benefits
Company Culture
Technical.ly Coverage

At Pinnacle 21, we are always looking for exceptional team members. Our company and team are still in its earlier stages, meaning you will be crucial to shaping the future of company’s Quality and Compliance systems. As we plan to make a lasting impact on the pharmaceutical industry we’re looking for a motivated member to take part in fostering one of the top companies in Philadelphia!

Work that matters Our teams work with the pharmaceutical industry to streamline the drug approval process, bringing life-saving medicines to patients that need them. We need to ensure everyone is informed, educated, and in sync to allow for a seamless and collaborative work experience.

Work autonomously ​Enjoy an autonomous environment, where we’ll support your continuous improvement and foster your capabilities to manage ownership of multiple areas and projects in order to continually grow your skillset.

Global footprint We support a community of users from countries across the world that widely regard our software as the industry standard for clinical submission preparation.

 

What you’ll be doing

Our QA team is responsible for quality assurance, quality control, and compliance operations at Pinnacle 21. The QA manager will establish quality plans and policies and report to senior management on a regular basis on compliance activities and findings. They will design, implement, and maintain QA and compliance programs including the quality infrastructure (SOP system, training program, and internal/external audit coverage). The QA manager will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP regulatory environment.

  • Develop, author, and approve Pinnacle 21 Quality Process Documentation
  • Provide GxP Quality Assurance oversight of vendors and maintain quality agreements
  • Responsible for reviewing and approving all validation deliverables. As well as approving the test scripts
  • Responsible for reported non-conformances, deviations, and manage product complaint investigations and GXP archives
  • Ensure training programs meet GXP requirements
  • Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable Pinnacle 21 SOPs, GXP regulations and applicable client specific standards
  • Oversee compliance (GMP and GCP) auditing program to fulfil regulatory requirements.
  • Ensure CAPA findings from audits and regulatory inspections are effectively investigated and closed out
  • Provide expertise and guidance to Pinnacle 21 departments in interpreting and implementing governmental and agency guidelines to assure compliance.
  • Follow applicable regulations, including FDA, ICH, GXP, and Pinnacle 21 policies and procedures.
  • Ensure that direct reports and consultants have completed the training necessary for their assigned responsibilities.
  • Represent QA at project team meetings
  • Provides Quality Assurance input to Company strategic goals in form of schedules, quality plans, and budgets.

 

What we’re looking for

Must

  • Demonstrable knowledge of international GMP regulations and guidelines, industry practices, and experience implementing Quality systems in a regulated environment
  • Experience in managing and implementing a full software development life cycle
  • Working knowledge of GLP and GCP international regulations
  • Ability to critically review various types of internal documentation
  • Outstanding written and verbal communication
  • Excellent project management and leadership skills
  • Anticipate and resolve issues independently with the understanding of when to seek assistance
  • Strong attention to detail, organization and time management skills
  • Ability to work as a team player with multi-disciplinary project teams
  • Proficiency in Office 365 and other commonly used business solutions
  • Minimally a BS degree in STEM, Masters preferred

Plus

  • Prior experience within a growing software company
  • Prior experience within Clinical Trials or Life Science industry

A bit about us

Pinnacle 21 is a startup making a big impact on regulatory review processes. Our flagship software provides the biopharmaceutical industry with the key to a fast, efficient drug review process. It’s this technology that drives FDA’s 21st Century Review Initiative, ensuring that submission data is compliant, useful and ready for review — which enables a more efficient review process. Our Great Place to Work certified workplace is constantly looking for new, motivated team members to come help us revolutionize clinical trials.

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Health & Wellness Benefits
  • Dental
  • Disability Insurance
  • Health Insurance
  • Life Insurance
  • Onsite Gym
  • Vision
Other
  • Game Room
  • Work from Home
Parental Benefits
  • Family Medical Leave
  • Flexible Work Schedule
Perks & Discounts
  • Casual Dress
  • Company Outings
  • Lunch
  • Snacks
Retirement & Stock Options Benefits
  • 401K
Vacation & Time Off Benefits
  • Generous PTO
  • Paid Holidays
  • Paid Sick Days

What are the benefits of working at a small company like Pinnacle 21?

There’s incredible impact to be made. Anyone coming in will be able to get their hands on a lot very quickly and represent their own piece of the pie here. You can count on having true ownership of the work.

Being a small company, we’re very malleable. At our current stage, any engineers coming in will be able to accelerate what we’re doing and how quickly we’ll be able to take the next steps. We have a very aggressive product roadmap and the only thing we need now is that next wave of talent.

What does Pinnacle 21 look for in prospective employees?

We look for people who are autonomous, resourceful, and scrappy. We’re driven by speed and efficiency. We want to make sure the job is getting done in the quickest and most effective manner. But we don’t work fast and just let quality go out the window. We work smarter, not harder.

What kind of tech skills do you expect candidates to have?

For Full-Stack Engineers: Java, JS, Play Framework, ReactJS, Redux, Postgres, AWS, and experience in Agile

How does Pinnacle 21 invest in employee growth and learning?

We encourage professional growth in a number of ways. We will always support you through educational opportunities, growth and mentorship. There’s also no shortage of challenging projects that will further your career.

We offer employees the opportunity to go to one conference a year, on us. We also encourage our people to take professional training courses on behalf of the company.

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