Quality Assurance And Regulatory Affairs Manager Jobs

Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.

Many years in complex projects or programs including first experience in portfolio management.

Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.

Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.

Experienced in strategic planning and risk management.

MS Project and project management tools.

Management review of quality and regulatory team.

Manage the preparation and development of regulatory submission packages.

Oversee document control, internal and external audits, complaint system, CAPA, NCMRs, and key supplier qualifications.

Prior experience authoring and filing of regulatory documents.

Responsible for regulatory submission strategies to support product development and approval of various medical device products.

Interface with regulatory authorities and internal technical teams on regulatory submissions.

Maintaining a working knowledge and thorough understanding of federal and institutional regulations and polices relating to human subjects research

2+ years of experience in clinical research

Experience using electronic regulatory platforms a plus

Experience with industry-sponsored clinical trials preferred

Conducting internal auditing and monitoring activities to ensure compliance with study protocols and applicable regulations

Assisting investigators and clinical research coordinators in preparing for site monitoring visits and audits

Responsible for supporting the management of an operating budget for the department.

Maintains current knowledge of quality improvement information, patient safety, and regulatory requirements.

Coordinates all documentation requirements for the Performance Improvement and National Patient Safety Goal chapters of The Joint Commission manual.

Supports the coordination and direction all activities to ensure the effective implementation of the Quality Improvement Plan.

Designs, develops, implements and evaluates quality improvement policies and procedures.

Develops and facilitates the use of data collection tools to support data analysis.

Experience and knowledge of all call center KPI & SL metrics.

Experience in driving change via business cases for transformation.

BA/BS in Business, communications. Equivalent years of experience in the business operation field and or medical device.

Experience of managing a critical path regarding customer complaints would be advantageous

Hands-on experience with service and support workflow tools such as ServiceNow, SFDC, Veeva, Oracle Zendesk.

Strong communication skills, expresses ideas fluently and logically, is open to input and can be depended on for truthfulness.

Uses prior experience to ‘see around corners’ and anticipate changes needed to reflect growing complexity in strategy and business operations.

Experience working in global organizations and managing and building geographically dispersed teams preferred.

Partner with key stakeholders to ensure that quality strategy is aligned with business strategy to achieve company objectives

Maintain transparent reporting on KRIs and KPIs related to food safety and quality, sanitation, and internal and external audits.

Ensure regulatory compliance across all BYND activities.

Bachelor’s degree in Food Safety, Microbiology, Chemistry, Food Science, or other related field. Master’s degree highly preferred.

Manage compliance: Ensure products adhere to all relevant safety, health, and environmental requirements imposed by local, national, and international governing bodies.

Improve supplier quality: Drive improvements in suppliers’ quality management systems.

BA/BS degree in a related field such as Engineering, Quality Assurance, Regulatory Affairs, or Risk Management

Provide leadership: Offer high quality and effective leadership to team members and present development opportunities to staff.

Experience within a product testing lab/facility is highly desired.

Excellent communication skills, with the ability to articulate complex compliance issues and potential risks to cross-functional partners and stakeholders.

Excellent interpersonal skills and experience working with different personalities, cultures and levels of management.

Many years in complex projects or programs including first experience in portfolio management.

Strong analytical, multitasking, time management, and organizational skills with focused attention on detail.

Strong knowledge of project management concepts, tools, templates and methodologies and when to employ them.

Experienced in strategic planning and risk management.

MS Project and project management tools.

Proficiency using Google Suite & Microsoft Office programs; experience with task management software is a plus

Manage workflows for internal processes and share/implement ideas for continuous improvement of these processes

Experience working in an FDA-regulated industry (food industry is preferred)

Knowledge of Good Manufacturing Practices (GMP) and Enterprise Resource Planning (ERP) systems

Some knowledge of food additive and/or crop protection regulatory framework preferred

Highly organized and with a strong ability to manage multiple priorities in parallel with each other

12+ years related GMP experience in biotechnology, chemistry, biochemistry, microbiology, pharmaceutical, manufacturing, or laboratory environment. 7-10 years experience in Quality Management.

Expert knowledge of GMP, FDA, and EMA regulatory requirements applicable to Biologics including Cell/Gene/Viral therapy products

Regulatory Knowledge CBER, CDER, CDRH, and other global agencies

Experience interacting with FDA and other global agencies

Ability to prepare audit reports, quality agreements, standard operating procedures, and CAPA reports in accordance with companies Quality System requirements

Experience leading a Quality Dept at a CDMO (preferred)

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

Monitors the overall compliance program at the operating level and works closely with the CSRA Manager.

Tracks and maintains records as per regulatory requirements.

Participates in the investigation of compliance-related incidents, under the direction of the CSRA Manager or CSRA Director.

In the CSRA Manager’s absence, operates as liaison for the DC with Federal, State and local regulatory agencies.

Knowledge of legal and regulatory compliance regulations

Manage all aspects of regulatory affairs, including preparing and submitting regulatory submissions, reviewing labeling and advertising materials, and maintaining regulatory documentation.

3+ years of experience in regulatory affairs and quality engineering in the medical device industry.

Experience managing product submissions and interfacing with regulatory bodies.

Excellent problem-solving and analytical skills, with a keen attention to detail.

Strong interpersonal and communication skills, with the ability to work effectively in cross-functional teams.

Lead quality control efforts, conducting product testing, analyzing data, and identifying areas for improvement in product design and manufacturing processes.

Ensure the qualification, selection and management of vendors and contractors through a defined qualified process

Design and maintain a fit-for-purpose quality management system (QMS) across the GxPs

Develop and manage Global Regulatory Affairs and QA budgets

Extensive experience leading, designing, writing and submission of regulatory filings and correspondence

Excellent written and oral communication skills and the ability to effectively communicate with internal and external team members on project activities

Strong problem solving, critical thinking and analytical skills, required to make sound decisions

Advanced oral and written professional communication skills; agile and efficient time/project management.

Participate in pre-development assessment of formulations for corporate compliance, including SDS management, CARB, Proposition 65, ingredient selection, and nanotechnology.

2-4 Specialist years of cosmetic/personal care regulatory experience with a knowledge of cosmetic ingredients.

Help manage and track product liability claims, liaising with department heads & insurance companies.

Working knowledge of US cosmetic and OTC drug regulations.

Medical/510K experience & Quality Assurance experience are a plus.

Applying QMS to project management

o Customer service management and Complaint Handling

o Management Review (the non-boring version)

o Risk Management ISO 14791

applying QMS to project management

A working knowledge of ISO and Regulatory Compliance

Organized individual with the ability to manage multiple priorities while maintaining high performance standards

Becoming familiar with laws, guidances, and regulatory requirements for drugs and combination products

Excellent written, verbal, and presentation skills and strong interpersonal skills

Working with regulatory subteams to support development and execution of regulatory strategies for compounds in development and/or for marketed products

Supporting submissions to relevant health authories across the globe

Researching and interpreting guidances and resources issued by health authorities and providing information to project teams to aid in strategic decisions

Regulatory Reporting Quality Assurance Associate

POSTING DATE: Apr 18, 2023

PRIMARY LOCATION: Americas-United States of America-New York-New York

OTHER SKILLS, ABILITIES OR QUALIFICATIONS

Project Management, Change Execution Management and Team Leadership experience in a Quality function a plus.

·Management of QA, QC, and Compliance team

·Demonstrated supervisory experience, leadership, and teamwork skills.

Ability to work independently as well as manage teams.

Strong quality mind and technical knowledge.

Manage quality systems, and inform senior leadership in compliance with quality system requirements

Participate with leadership in setting strategic direction and developing the capabilities of the QA/RA team

Bachelor's degree and 10+ years of related experience

Strong knowledge of quality and regulatory standards pertaining to surveillance testing, approved diagnostics, and sample collection kits

High level of knowledge of business operations, objectives and strategies

Excellent problem-solving and decision-making skills

A minimum of 3 years supervisory or management experience required.

Coordinate and Manage Supplier Qualification and Vendor Qualification processes. Maintain all applicable documentation and records.

Process Improvement activities including developing statistical reports for tracking and trending quality system reports for reporting to executive management.

Working knowledge of federal and state requirements for human subject research protection, peripheral stem cell collections, and blood donor centers.

Support regulatory inspections and Supplier Qualification Audits, coordinate responses, maintain all applicable documentation and records.

Monitor all applicable government and accreditation agency regulations and requirements to ensure compliance. Notify operations of regulatory changes.