MC Life Sciences Senior Associate

We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, inclusive culture and talent experience and our ability to be compelling to our clients. You'll find an environment that inspires and empowers you to thrive both personally and professionally. There's no one like you and that's why there's nowhere like RSM.

Position Description

As a Senior Associate within the Life Sciences Management Consulting practice, you will become a leader in one of the fastest growing and most entrepreneurial groups within RSM. You will have the resources and cross functional support of the largest middle market firm but will be able to operate in a lean and agile environment where your ideas and experience can directly shape what service offerings we provide to our clients and how we approach them. We are continually looking to expand our scope of services and industries and need your help to do it.

We are looking for consultants that can solve the complex problems the middle market faces throughout the entire value chain. We need leaders that can identify the real problems our clients are facing and use data to prescribe innovative strategic and operational solutions. Finally, we need people that can effectively communicate with clients and team members and foster long lasting relationships.

The ideal candidate will have experience in at least three of the following performance improvement initiatives:

• Work experience authoring or revising standard operating procedures (SOP) through a quality change control process
• Supporting both FDA and internal quality audits
• Manufacturing operations for MedTech, Biotech, or Pharma
• Leading CAPAs/NCMRS/OOTs
• Process validation and verification
• Incoming quality inspection and designing specifications
• Extensive knowledge on FDA regulations and requirements
• Knowledgeable on QMS structure and effective deployment
• Experience working with a digital quality management system (QMS), manufacturing execution system (MES), or laboratory information system (LIMS)
• Digital signature validations for 21 CFR Part 11 Compliance

• Lean Six Sigma
• Quality Management

Responsibilities:

• Provide analytical support and industry insight during client assessments to understand and define the current state through data, opinions, observations, interviews and facilitated workshops
• Identify business drivers and prioritize personal work efforts quicky to maximize productivity in engagements
• Propose, develop, and implement solutions to complex client initiatives to achieve the desired future state
• Communicate effectively both internally with the engagement team and externally with client employees, C-suite executives and/or private equity partners to maintain excellent client relationships
• Support management in business development, networking, proposals, and marketing content
• Support management with engagement economics such as proposal budgeting and pricing, margin management, billing, risk management, etc.

Basic Qualifications:

• Bachelor's degree in engineering (biomedical, mechanical, computer, chemical, or industrial)
• Experience as a quality engineer or within a quality function
• Have worked in a GMP environment
• Senior Associate: 3+ years of professional consulting experience or relevant industry experience
• Excellent critical thinking skills and ability to solve complex business problems through fact gathering, business process mapping and data analysis
• Ability to deal effectively with ambiguity
• Excellent verbal and written communication, project management, and organization skills
• Client service and relationship building skills
• Must be a team player; demonstrate attention to detail and problem-solving skills; able to effectively work independently and in a team environment
• Willingness and ability to travel 50%+

Preferred Qualifications:

• Lean Six Sigma Green belt
• MBA or advanced degree
• Consulting Presence and ability to communicate with persons in executive level roles
• Project Management certification
• Knowledge on Global Regulatory requirements

At RSM, we offer a competitive benefits and compensation package for all our people. We support and inspire you to prioritize your wellbeing by delivering personalized, holistic programming for your physical, emotional, financial and community wellbeing. RSM has a generous time off policy with at least 14 paid holidays, wellbeing days and associate and above access to self-managed time off. We offer flexibility in your schedule, empowering you to balance life's demands, while also maintaining your ability to serve clients. Learn more about our total rewards at https://rsmus.com/careers/working-at-rsm/benefits .

RSM is proud to be an Affirmative Action and Equal Employment Opportunity employer. We are proud to provide our employees with tools to assist them in being successful in achieving both personal and professional goals. We welcome and support all our employees to thrive in an environment free of discrimination and harassment. As an Affirmative Action and Equal Opportunity Employer all applicants will receive consideration for employment as RSM does not tolerate discrimination and/or harassment based on race; color; creed; sincerely held religious beliefs, practices or observances; sex (including pregnancy or disabilities related to nursing); gender (including gender identity and/or gender expression); sexual orientation; HIV Status; national origin; ancestry; familial or marital status; age; physical or mental disability; citizenship; political affiliation; medical condition (including family and medical leave); domestic violence victim status; past, current or prospective service in the US uniformed service; pre-disposing genetic characteristics or any other characteristic protected under applicable federal, state or local law.

Accommodation for applicants with disabilities is available upon request in connection with the recruitment process and/or employment/partnership. RSM is committed to providing equal opportunity and reasonable accommodation for people with disabilities. If you require a reasonable accommodation to complete an application, interview, or otherwise participate in the recruiting process, please call us at 800-274-3978 or send us an email at [email protected] .

RSM does not intend to hire entry level candidates who will require sponsorship now OR in the future (i.e. F-1 visa holders). However, those candidates who may be recent U.S. college / university graduates possessing 1-2 years of progressive and relevant work experience, excluding internships, in the U.S. or his/her home country would be eligible for hire as an experienced candidate and thus eligible for sponsorship.

If you have questions, please reach out to your recruiter. If you are unsure who your recruiter is, please reach out to our immigration question mailbox at [email protected] for assistance. Only questions specifically related to sponsorship will be considered and answered by the global immigration team's mailbox.

Compensation Range: $93,200 - $186,300