Join Our Team of FDA Experts

EMMA International uses consultants for a variety of different projects and we are always looking for consultants to be considered for new projects. To become a consultant, fill out the consultant questionnaire.

Position Summary

As a key member of the executive leadership team, the VP of Business Development is responsible for leading existing and future business development and to position the company for leadership in its target segments. Will create and implement a revenue growth plan that leverages the company’s successful track record by bringing in new accounts with significant revenue potential to meet the company’s ambitious growth goals.

Essential Duties

• Lead the sales and business development efforts for EMMA International.
• Responsible for creating and implementing strategies for targeted regional growth.
• Identify and develop strategic plans to cultivate new business opportunities.
• Responsible for the creation of an annual sales and business development strategy.
• Achieve or exceed monthly, quarterly and annual sales and growth goals by securing new business.
• Responsible for maintaining strategic relationships with customers and partners.
• Monitor client satisfaction with existing clients to ensure service delivery.
• Have other duties as assigned.

Qualifications

• Experience and in-depth knowledge of life science companies.
• Ability to build consensus and relationships among executives, partners, and the workforce.
• Outstanding organizational and leadership abilities.
• Ability to work under pressure, plan personal workload effectively and delegate.
• An entrepreneurial mindset with outstanding organizational and leadership skills.
• This is not an exhaustive list of qualifications

Education

• Master’s degree in Business Administration or equivalent executive level experience
• Bachelor’s degree in Life Sciences or Business

Working Conditions

• The work will be performed in an office environment.
• Requires travel to client sites and trade conventions.
• Minimal physical effort will be required in this position.
• Workdays: Monday – Friday, 8:00 a.m. – 5:00 p.m.

Full-Time (On-Site)

Bingham Farms, MI

 Company Overview

EMMA International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Bingham Farms, Michigan.  We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.

Position Summary

Responsible for the development, maintenance, and implementation of specifications and standards for processes, materials, and products in accordance with quality programs, plans, SOPs and policies of the company’s Quality System and in compliance with FDA regulations, ISO 13485, and other regulatory requirements as applicable.

 Essential Duties

• Assist in the development, implementation, and maintenance of Quality System specifications and requirements in accordance with cGMPs, ISO 13485 and other International regulations as applicable.
• Direct and/or participate in projects directed at the development and implementation of quality standards throughout the company.
• Participate in department meetings to provide input into the design and implementation of product specifications.
• Write, review and edit documents and SOPs as required.
• Assist during FDA inspections, ISO Certification and surveillance audits and customer and supplier audits.
• Assist in validation activities and development of requirements and specifications.
• Follow-up on corrective action responses, ensuring implementation of appropriate problem resolution methods and verifying effectiveness.
• Facilitates problem-solving activities, team building and quality systems tools and methodologies.
• Collaborate with other departments and functions on continuous improvement opportunities of the Quality System.
• Carry out other duties as required or assigned.

Qualifications

• Experience developing and implementing quality plans and programs. ASQ certification (CQE, CRE) is preferred. Working knowledge and experience of FDA’s Quality System requirements (QSR), ISO 9001 and ISO 13485 standards. Ability to coordinate multiple project schedules and activities.
• The candidate should have strong analytical, communication and interpersonal skills. Strong linguistic, grammar, and editing skills. Ability to multi-task in an environment with changing priorities. Strong statistical training, skills and experience.
• Proficiency with Microsoft applications Word, Excel, Project, Visio, and PowerPoint. And ability to learn additional software applications, as the need arises.
• This is not an exhaustive list of qualifications

Education

BS or MS degree in technical/scientific/engineering discipline, with at least 2+ years of experience in medical devices, in vitro diagnostics or a related industry.

Working Conditions

• The work will be performed in an office environment.
• Minimal physical effort will be required in this position.
• Work days: Monday – Friday, 8:00 a.m. – 5:00 p.m.

Full-Time (On-Site)

Bingham Farms, MI

 Company Overview

EMMA International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Bingham Farms, Michigan.  We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.

Position Summary

As a Regulatory Scientist, you are responsible and accountable for developing and executing sound strategies for regulatory activities for new products. You will interact with clients to ensure the timely preparation of organized and scientifically valid applications to regulatory bodies.    

 Essential Duties

• Develop regulatory strategies for moderately to highly complex submissions to FDA and other regulatory authorities. Ensure timely submissions and approvals of pre-market submissions and marketing applications.
• Act as a liaison between clients and regulatory authorities regarding submissions.
• Interpret statutes, regulations, policies and guidance documents for business teams and product development/support teams, communicating how these impact product development, manufacturing, and/or marketing.
• Remain current on regulatory issues/trends affecting business unit products; assessing and communicating their impact to regulatory affairs colleagues, product development/support teams, and to others in the business.
• Develop, implement, and maintain departmental Standard Operating Procedures (SOP’s).
• Provide expertise in translating regulatory requirements into training documents.
• Other duties as assigned.

Qualifications

• 5+ years experience in the biotechnology, pharmaceutical, or other FDA-regulated industry.
• Demonstrated knowledge and application of regulatory requirements, international standards, and regulatory science.
• Demonstrated experience in interfacing with regulatory authority review staff and inspectors.
• Demonstrate strong project management, writing, and customer service skills.
• This is not an exhaustive list of qualifications

Education

MS degree or PhD in technical/scientific/engineering discipline, with at least 2+ years of experience in medical devices, in vitro diagnostics or a related industry.

Working Conditions

• The work will be performed in an office environment.
• Minimal physical effort will be required in this position.
• Work days: Monday – Friday, 8:00 a.m. – 5:00 p.m.

Full-Time (On-Site)

Job Summary:

EMMA International, a leading consulting firm in the medical device, pharmaceutical, biotechnology, combination products, and diagnostics industries. We are seeking a highly motivated and experienced consultant to join our team. The successful candidate will be responsible for supporting our clients in the pharmaceutical manufacturing industry by providing technical expertise in areas such as microbiology, regulatory affairs, technical writing, Lean Six Sigma certification, and root cause analysis.

Essential Duties:

• Provide technical expertise and support to clients in the pharmaceutical manufacturing industry.
• Perform root cause analysis and recommend corrective actions to address quality issues.
• Develop and review manufacturing procedures, including batch records, standard operating procedures, and protocols.
• Ensure compliance with relevant regulations and guidelines, including FDA, cGMP, and ICH.
• Conduct risk assessments and implement mitigation strategies.
• Support clients in the implementation of Lean Six Sigma methodologies to improve operational efficiency and reduce waste.
• Communicate effectively with clients and stakeholders, including presenting technical information in a clear and concise manner.
• Collaborate with cross-functional teams to drive projects to successful completion.

Qualifications:

• 3+ years of experience in pharmaceutical manufacturing, with a strong understanding of cGMP, FDA regulations, and ICH guidelines.
• Lean Six Sigma certification, with a proven track record of implementing process improvements.
• Strong technical writing and communication skills.
• Experience with root cause analysis and risk assessment.
• Ability to work independently and as part of a team.
• Strong analytical and problem-solving skills.
• Must have advanced experience with investigation
• Bio/Pharma industry experience preferred

Education:

• Must have BA/BS in Biochemistry, Chemical Engineering, Biology or other relevant science discipline
• Must be willing to work additional various shifts as required
• Must be willing to work on-site at client facility
• Must have prior experience working in a manufacturing environment and troubleshooting manufacturing related issues

If you have a passion for consulting and are looking for an opportunity to work with a dynamic team of experts, please apply today!