Lead auditor job description

RQM+ is the largest medical device and diagnostics focused full-service regulatory and quality consulting firm in the world. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities.

With over 500 team members globally, providing world-class consulting services in a remote capacity is nothing new for RQM+. We are dedicated to the highest levels of client service and employee satisfaction delivered with empathy, integrity, individual pride and company spirit.

RQM+ is looking for a pool of ISO 13485 Lead Auditors for upcoming audits. The auditing will cover the overall effectiveness of client's QMS to identify gaps internally prior to during an external audit with notified body. These will all be domestic audits (1 day/ 2 day/ 3 day). Will be asked if interested when each audit need arises.

Utilizing their past experience in engineering, design, or quality control of medical devices, our QA Auditors conduct ISO 13485/MDSAP audits and CE Marking activities for clients to ensure products meet international standards and are go-to-market ready.

Manage audits on a contract/project basis. All audits are short term maximum three days. Paid at hourly rate. 18 hours minimum for one-day audit. Client management includes contacting them to schedule the visit, planning the assessment, making appropriate travel plans, conducting assessments, and completing reports.

ResponsibilitiesAnalyze quality systems and assess Quality Management Systems according to ISO Standards ISO 9001:2015 and ISO 13485:2016.CE Marking certification under the applicable European Directives & Regulations Medical Devices 93/42/EEC (MDD).CE Marking certification under the applicable European Directives & Regulations Active Medical Device Implantable 90/385/EEC (AIMD).CE Marking certification under the applicable European Directives & Regulations In Vitro Diagnostics devices 98/79/EC (IVDD).CE Marking certification under the applicable European Directives & Regulations EU MDR 2017/745.CE Marking certification under the applicable European Directives & Regulations EU IVDR 2017/746.CE Marking certification under the applicable European Directives & Regulations Quality Management Systems under the requirements of the Medical Device Single Audit Program MDSAP.

RequirementsBachelor's degrees in related field. A minimum of four years of full-time hands-on (R&D, manufacturing, testing and/or auditing) work experience in the field of medical devices or related sectors.At least two years in the area of quality management (experience working in an organization governed by regulations and standards).Lead Auditor Certificate - Med Devices.

Being an industry leader in client support is just the beginning for RQM+. Providing a rewarding place to work is rooted deep in the core values of RQM+. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ applies the “and means more” approach to employment. At RQM+, you are not just another employee, you are a member of the RQM+ family. Make your impact today!
We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us.

With recent approvals in the US and Canada Amylyx Pharmaceuticals is launching a new drug for the treatment of adults with ALS.

If you are looking for a place where your work can have a deeper impact than you ever imagined and where you can be true to yourself - Amylyx is the place for you!

At Amylyx, we're bringing together talented people like you who are committed to solving for humanity's most devastating diseases, including amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and others-all in a uniquely supportive, respectful environment that rewards innovative thinking, committed teamwork, and boundless curiosity.

Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences-in all the best ways.

We provide a competitive employee benefits package including stock options and RSUs; flexible work options including hybrid and remote; discretionary time-off; comprehensive healthcare, including dental and vision coverage; and retirement savings benefits.

This newly created position will be a key member of the Quality Leadership Team. The Lead, Quality Audit Management is accountable for supporting the risk-based vendor management program for Amylyx GxP Quality, and for providing support in presenting the program during regulatory inspections, if required. The individual is responsible for planning, conducting, and closing GxP vendor audits to assess Amylyx's vendors and clinical site's level of compliance with GxP regulations, guidelines, internal procedures, and industry best-practices. In this role you will act as the secondary contact point for all audit related communication with vendors. You will be responsible for supporting the maintenance of the approved vendor list and sustainment of the Quality Technical Agreements program.
RESPONSIBILITIES
* Support development of yearly audit plan per internal procedures and manage using the eQMS system.
* Execute and close out internal and external audits per an approved audit schedule, and write audit related documents (agendas, reports, etc.).
* Document audit observations, evaluate auditee's responses and CAPAs in electronic system and monitor until closure.
* Determine and document decisions on supplier qualification status, escalate critical findings to Senior Management.
* Perform risks assessments for new vendors and maintain and update the approved vendor list.
* Write, revise, and review procedures for the supplier management program and generate KPIs for audit management.
* Participate in regulatory audits, PAI readiness audits, BIMO readiness visits and inspections as directed by QA Management.
* Support Technical Quality Agreements management, write TQAs using an internal template, and communicate with suppliers for comment resolution and approval. Monitor periodic QTA review dates and follows up on revisions.
* Participate in cross functional projects and provide back-up to for the QA department, as needed.
* Up to 50% travel, domestic and international.
REQUIREMENTS
* BS / MS in a scientific or engineering discipline
* Minimum of 8 years of experience in pharmaceutical / biotech industry within Quality Assurance, executing audits at following vendor types:
* API Manufacturers (small molecules, preferred)
* Oral Dosage Form Drug Product Manufacturers e.g. tableting, capsules, etc.
* Clinical Warehouses and Distribution Centers for clinical and, preferable also for commercial drug products
* CROs
* Clinical Investigator Sites
* BIMOs (US and EU)
* Packaging and Labeling operations
* PAIs
* Contract Testing Labs
* Working knowledge of:
* Writing and negotiating Quality Agreements
* Regulatory Compliance, Quality System Management and Quality Assurance principles and practices
* QMS electronic platforms
* FDA and EU cGMP requirements as applicable to GxP areas
* Write and revise GxP documents
* Use judgment in situations for which there are no precedents
* Outstanding communication skills (verbal and written)
* Ability to manage multiple projects, in a fast-paced environment
* Self-motivated, organized, and strong technical skills
COVID-19 Vaccination Policy: Candidates should be aware that Amylyx's current COVID-19 policy requires that all newly hired US-based employees be fully vaccinated against COVID-19 prior to their employment start date. Amylyx may amend its COVID-19 policy going forward, including, but not limited to, requiring booster vaccinations. Amylyx is an equal opportunity employer. As required pursuant to federal, state, and local law, Amylyx will provide a reasonable accommodation to the vaccination requirement where vaccination is not a requirement of the role for which the employee is being hired and is not an undue hardship to the company.
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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

At AT&T we're redefining the future of connectivity. At our core is a passion to serve our customers with products and services that create connections, improve lives and allow millions to share the stories and experiences that matter. Our Corporate teams are fueled by innovation and a desire to connect the world in meaningful ways. Join our team and bring your bold ideas, supporting and transforming our business across areas like marketing, finance and more.

As a Lead Auditor, you'll be responsible for coordinating and executing internal audits. You'll conduct all phases of the audit process including planning, fieldwork, communication, and corrective action follow-up. You'll also develop audit reports that provide recommendations for improving business processes and internal control procedures. You will mentor and provide feedback to audit team members throughout the audit process. Your previous supervisory or management experience will be instrumental to your success, as this highly visible position has the potential to progress into a supervisory role.
Key Roles and Responsibilities:

• Perform walk-through of system functions, business processes and operational procedures

• Identify internal control designs and evaluate control effectiveness

• Develop risk-based audit test plans and gain an understanding of the specific issues that require evaluation

• Analyze transactional data, business reports and other financial and operational records to verify data processing integrity and identify discrepancies

• Communicate audit results and conclusions to departmental and company leadership

Experience and Education:

• 5+ years experience in internal or external audits

• CPA, CIA, CISA or other audit-related certification

• Experience in executing all phases of audits including developing audit programs, conducting detailed fieldwork testing, formulating conclusions and presenting results to management

• Demonstrated abilities in performing audits related to Information Technology general controls

• Audit experience with Big 4 or national public accounting firm preferred

**Currently hiring in the Atlanta, Dallas, San Antonio and St Louis areas for a hybrid office role.**

Our Lead Auditors earn between $94,300 & $141,500, not to mention all of the other amazing rewards that working at AT&T offers. From health insurance to tuition reimbursement and paid time off to discounts on products and services just to name a few. There is a lot to be excited about around here.

A career with us, a global leader in communications and technology, comes with big rewards. As part of our team, you'll lead transformation surrounded by trailblazing industry leaders like you. You'll be empowered to go above and beyond - making a difference through company-sponsored initiatives or connecting and networking through one of our many employee groups. And regardless of where you're at in your career trajectory, you'll be rewarded by the impact that comes with making a difference in the lives of millions. With AT&T, you'll be a part of something greater, do incredible things and be rewarded with a chance to change the world.

Ready to join our team? Apply today!

AT&T will consider for employment qualified applicants in a manner consistent with the requirements of federal, state and local laws

We expect employees to be honest, trustworthy, and operate with integrity. Discrimination and all unlawful harassment (including sexual harassment) in employment is not tolerated. We encourage success based on our individual merits and abilities without regard to race, color, religion, national origin, gender, sexual orientation, gender identity, age, disability, marital status, citizenship status, military status, protected veteran status or employment status