Quality assurance engineering manager job description

The Sarepta Therapeutics QA Compliance Unit is seeking to fill a Full-Time position for Sr. Manager, Quality Engineer, to assume primary responsibility for development and maintenance of GxP production quality standards and documentation. This position will encompass both quality assurance and quality control as well as validation verification responsibilities. This includes but is not limited to: defining quality requirements for new products and
preparing/maintaining
necessary documentation, monitor production quality performance to identify opportunities for improvement, review and maintenance of quality policies, procedures, etc. for relevance and adherence to Sarepta Quality Management System and patient and regulatory compliance.

Primary responsibilities include:

Develop and implement process to perform Quality technical review and trending of Sarepta product release testing and stability data for GMP laboratories per specifications Develop and implement process to review and maintain quality product specifications to drive timely revisions supported by robust justifications and technical design documents Notify/ escalate critical events and trends to management that impact the quality of product or manufacturing operations Proactively identify current and future risk and develop integrated action plans to mitigate negative impact Review and approve QMS record management to ensure completeness, compliance, timeliness, and effectiveness Develop and implement process to generate report of QMS and compliance metrics including monthly updates to cross functional QMS owners and in preparation for quarterly Quality Review BoardAct as QAC Lead for investigation activities (Deviations, Laboratory Investigations, CAPA activities, etc.) associated with GMP oversight, OOS, product complaints, including escalation activities as applicable, e.g., field alerts and/or recalls and global regulatory notifications to provide timely and meaningful feedback Guide design and execution of detailed deviation investigation hypothesis testing with pre-defined acceptance criteria as part of root cause analysis with purposes of determining corrective actions to ensure product quality Perform Quality technical review for change control submissions Support Regulatory Inspections and regulatory submissions Author, review, and approve of GMP Controlled DocumentsDraft, edit, revise and update as necessary all documents associated with the QMS, Quality Manual, and Site Master File.Write and coordinates product annual product reviews with Sarepta internal reviewers and applicable CMOs/Contract testing labs Participate in special projects as assigned

Desired Education and Skills:
B.S. or B.A. degree (preferably in Life Science) and ten years relevant experience in the pharmaceutical or biopharmaceutical industry Quality professional with 5+ years of hands-on experience with increasing responsibility in a QA and/or Quality Engineering function Excellent leadership and management skills, prior supervisory experience in a pharmaceutical environment Significant GMP experience in either clinical and/ or commercial products, global experience Extensive knowledge of US GxP compliance regulations and industry practices, as well as EU GMP requirements Extensive knowledge of GMP Quality Management System (QMS) oversight for compliance Excellent communication and organizational skills, as well as negotiation, influencing, and collaboration skills, and demonstrated ability to work cross functionally across internal stakeholders Proficient in building consensus, negotiating, and escalating issues and risk management Good understanding of the importance and use of quality metrics US FDA/EU inspection experience (participating or leading) Demonstrated continues improvement experience (i.e., six sigma certification) Excellent command of spoken and written English language; the ability to clearly express complex ideas verbally and in writing Ability to perform statistical analysis Ability to handle high pressure environment associated with meeting deadlines Ability to collaborate and get along well with co-workers Independent: able to work with minimal supervision; demonstrate initiative and self-direction Ability to manage multiple concurrent projects and to deliver results accurately and on time Interpersonal skills including teamwork, listening, giving feedback, giving instructions, and conflict resolution

This position is a facility-dependent role which requires work on site at one of Sarepta's facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based workers to be fully vaccinated against COVID-19 in order to work on site. Facility dependent contractors must be vaccinated prior to their start date. Sarepta is an equal opportunity employer and will honor any reasonable accommodation that a contractor has in place with his or her employer, where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

#LI-ES1

We are looking for highly driven engineering leaders to join our growing team at Northern Labs. At the manager and director level we're looking for people that specialize in one or more of Blockchain, Frontend, Backend and QA Automation. At Northern Labs we believe that in order to manage technical teams, you need to be technical yourself so we don't split the role of Tech Lead from Manager. And Managers are hands on.

Engineering Managers work in concert with the product manager and product designer to guide software projects to success. Some days this will mean collaborating with engineers to make sure systems are being built well and nothing is falling through the cracks. Other days you will communicate complex technical suggestions or constraints to stakeholders and designers. Success in this role is measured by developers who feel fulfilled and empowered to succeed, by project stakeholders who are informed and in control, and by the smooth delivery of world class software products.

WHAT YOU'LL DOServe as the voice of the developers. Understand the needs of each team (frontend, backend, blockchain, DevOps, etc) and represent those needs to leadership, stakeholders, and to each other.Think through design documents, vision-holder input, and other feature proposals with an eye for technical feasibility. Resolve corner cases and ambiguities through constructive debate. Solve problems before they happen.Work with PMs to task work and track progress toward milestones and product releases.“Be the hero.” Find problems and get them fixed through coordination, collaboration, and occasionally rolling up your sleeves and resolving things yourself when needed.Set a positive example. Share your wisdom and experience when team members need guidance or coaching. Foster a culture of humility, empowerment, and trust.Assist in recruiting. Review applications and conduct interviews with technical candidates.Hold routine 1-on-1 meetings with team members ensuring you are giving consistent feedback on performance.Author and maintain technical design documentation and diagrams.

WHO YOU AREOutstanding communication skills. Able to earn the respect of programmers as well as fellow managers and external partners.Ambition, eagerness to learn, a positive attitude, and the ability to work well in a team environment.At least 3 years experience leading developers.At least 2 years of hands-on senior level engineering experience in software, web development, or a related field.At least 1 project launched.Practical knowledge of systems architecture and the software development lifecycle.

BONUS IF YOU HAVEExperience with product design and human interface best practices.Knowledge of blockchain, distributed ledger technology, or distributed computing.Professional game development experience.Experience leading remote or distributed teams.Skill with UI design software (Sketch, Figma, Omnigraffle, etc).

Northern Labs is on a mission to lower the barrier to entrepreneurship in Canada and help companies grow to massive scale. As a Venture Studio, we use our deep technology expertise, capital and vast network to assist founders in turning ideas into viable companies. In addition, we partner with top tier venture backed startups to build out highly scalable, enterprise grade products and platforms.

We specialize in Blockchain, Fintech, Marketplaces, Analytics and Gaming and bring the expertise from building and scaling some of the best companies in the portfolios of Sequoia, Andreessen Horowitz, Battery Ventures, Bain Capital Ventures, GGV Capital and Altos Ventures.
A major advantage of working for a venture studio is diversified risk. You will have the opportunity to work on multiple products and startups, and you are not playing the startup lottery, hoping that the one startup you join will be one of the < 1% to give employees a positive exit.

At TechnologyAdvice, we pride ourselves on helping B2B tech buyers manage the complexity and risk of the buying process. We are a trusted source of information for tech buyers, delivering advice and facilitating connections between our buyers and the world’s leading sellers of business technology.

Established in 2006 out of our founder’s dorm room, we continue to expand our business. In 2021 we acquired TechRepublic, and in 2020, we acquired QuinStreet B2B, both leading resources for IT and business decision makers. These critical acquisitions included global teams of dynamic technology and media professionals to enhance our presences in the US, the UK, Singapore, and Australia. We now have more than 20 digital media brands and over 500 global team members, representing 12 languages.

Listed on the Inc. 5000 list of America’s Fastest-Growing Private Companies four times and a five-time recipient of the annual Tennessee Top Workplaces awards, we take both our growth and employee engagement seriously. We work hard each day, but we know how to have fun, too, with monthly virtual events, recreational slack channels, and the occasional costumed dance from our CEO.

The Opportunity…

Are you looking for a great career with a growing company where you can make an impact and be part of an exciting team? If combining your love for software engineering, passion for the web, and skill with technology sounds like an ideal job for you, you've found the right place!

We are looking for a talented full-stack software engineer to join us in our mission to push our technology to its limits. We have an “always learning” culture driven to improve as both individuals and as a team. If you are interested in being challenged, learning full-stack development, exploring DevOps, then TechnologyAdvice may be the next step in your career.

How You'll Contribute…

We are a Scrum-based engineering team focused on web technologies that strives to deliver business value quickly. Our team culture values the ideas and contributions of all members. We trust each other to maintain a high degree of ownership in our work, and always see things through to completion. We also like to have a bit of fun. When you’re not creating or maintaining business-critical software systems, you might be in a technical book club, participating in a hack-a-thon, or sharing your favorite hobbies over Slack.

You will play a vital role in our business and on our team by utilizing your quality assurance skills to propel our business forward. You will be responsible for:

+ Develops, implements, and manages processes to ensure that products meet required specifications for quality, function, and reliability prior to delivery.

+ Identifies and sets appropriate quality standards and parameters for products.

+ Communicates quality standards and parameters to QA team, product development team, and other appropriate staff.

+ Coordinates product testing processes.

+ Participates in product testing.

+ Identifies and analyzes issues, bugs, defects, and other problems, particularly when problems recur in multiple products; recommends and facilitates solutions to these issues.

+ Reviews client, customer, and user feedback.

What You Bring…

+ At least 3 years managing a QA team

+ Excellent verbal and written communication skills.

+ Excellent interpersonal and customer service skills.

+ Excellent organizational skills and attention to detail.

+ Experience with establishing a test suite ensuring quality for a consumer facing product

+ Excellent time management skills with a proven ability to meet deadlines.

+ Strong analytical and problem-solving skills.

+ Strong supervisory and leadership skills including establishing metrics and KPIs related to quality

Bonus Points…

+ Experience with Cypress, Jira, Datadog

+ Experience with managing offshore resources

Why You Want Us...

+ Remote/hybrid/in-office work options

+ Comprehensive health insurance (medical, dental, vision, life and disability)

+ 401(k) retirement plan with company match

+ Flexible PTO, take time off when you need it!

+ Paid maternity and parental leave

+ MacBook Pro or PC laptop, your choice

+ Ongoing career development meetings

+ Fitness reimbursement

+ Subscription reimbursement to the Headspace App

+ Live and remote fitness classes offered 5 days a week

+ Bucket List Benefit: We financially help you check something off your bucket list

+ Monthly team outings and quarterly volunteer opportunities

+ Professional development opportunities and incentives

+ Beer on Fridays! It’s 5 O’Clock Somewhere…

+ Milestone celebrations for birthdays, weddings, work achievements, and more

+ Coffee, snacks, ping pong, and catered lunches 4 days a week in office

Interviews will take place after resumes have been screened for minimum requirements. Please note that this position is not restricted solely to the responsibilities listed above and that the job scope and responsibilities are subject to change.

We believe that our differences make us stronger and foster a diverse and inclusive culture where people feel safe being themselves. TechnologyAdvice is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected under federal, state or local law.

Pre-employment screening required.

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COVID-19 RESPONSE:

TechnologyAdvice is committed to the safety and wellness of each of our employees. In response to the COVID-19 Pandemic, we follow all CDC and local protocol.

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