Talent.com
Client Development Lead, Validation and Regulatory Compliance
Client Development Lead, Validation and Regulatory ComplianceBarry-Wehmiller • Santa Ana, CA USA
Client Development Lead, Validation and Regulatory Compliance

Client Development Lead, Validation and Regulatory Compliance

Barry-Wehmiller • Santa Ana, CA USA
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Description

Client Development Lead, Validation and Regulatory Compliance (Design Group)

Who You’ll Work With

You will join one of our 45 offices in the US, be part of a committed team of over 1,500 professionals, and work in teams and directly with our clients doing work that is shaping the world around us. You will be welcomed into a rapidly growing business and team and empowered to make an impact. You will be valued, cared for, and challenged on your path to becoming a world-class professional consultant and surrounded by leaders who are committed to creating an environment that enables you to realize your own success and fulfillment.

When you join Design Group as a Client Development Lead, Validation and Regulatory Compliance, you are joining a team that will challenge you and position you for growth. In this role, you will work with a team of industry experts to help the world’s leading companies solve their most difficult problems. You will join our Regulatory Compliance Practice and partner with seasoned leaders, technical specialists, and subject matter experts to deliver the highest quality solutions to our clients with consistency and accuracy.

What You’ll Do

You'll work individually and in teams to support capital projects and implement solutions for our clients. Together, you will help our clients make critical changes to improve their performance and realize their most important goals.

As the Client Development Lead, Validation and Regulatory Compliance, you will be responsible for leveraging their past professional experiences, along with Design Group’s engineering offering to expand our presence in the Life Science market sector in the Southern California Area. The client development lead will lead a Regulatory Compliance Validation team for pharmaceutical, biotech and medical device manufacturing projects for our clients.

We seek a passionate, high achieving professional who thrives in a fast-paced, collaborative, entrepreneurial environment. A leader, mentor, coach with infectious enthusiasm who lifts others to his / her level and exhibits uncompromising dedication to client welfare. A subject matter expert who fully understands validation and regulatory compliance and can work with clients to develop diverse solutions to their problems. They also need to meet client needs and guide them in industry leading best practices for complex projects that require these scope services. Actively be involved in the execution and leading of all phases of projects.

  • Lead with an uplifting entrepreneurial spirit
  • Inspire excellence in all aspects of performance and project execution
  • Display enthusiasm and excitement for client projects that lifts project teams to high levels of job satisfaction
  • Consistently seek new value-add opportunities for clients and Design Group
  • Meet with clients to define the program requirements based on an understanding of the client's production process flow and space environmental needs derived from meetings with the client and the review of any documentation provided by the client
  • Assess the requirements of a project, break a project into tasks, and work with teams to determine scope of work, budget and staffing
  • Communicate and interact directly with clients in a collaborative and professional manner
  • Create integrated solutions and communicate key concepts to the client
  • Develop the base plan and coordinate technical requirements with engineering disciplines
  • Understand and develop design intent based on client objectives and provide excellent client service
  • Research material options to deliver an optimal solution for the client when required by project scope
  • Assign and review work of project team.
  • Check progress of work and alert project leads to change of scope or additional services.
  • Coordinate all aspects of project document completion within company and externally with clients and other design professionals. Proficient written and oral communications skills.
  • Prepare or review budgets based on experience and scope of project.
  • Assist in the education and development of the team and act as resource for questions.
  • Innovate and improve design and service delivery method and processes
  • Build and sustain long term client and internal relationships
  • Participate actively in relevant industry organization events and conferences
  • Make an impact day-to-day with your skills and expertise, strengthening that relationship with our clients and team

What You’ll Bring

  • A passion for a career in the Life Science industry
  • 15+ years of Life Science operational & engineering experience in the pharmaceutical, biotech or medical device sectors - Client side & Consulting experience highly preferred
  • 10+ years’ experience with increasing responsibility in validation / quality service and project management of life sciences, biotech or other FDA regulated projects
  • Diverse experience in leading CQV project teams related to the commissioning and qualification of clean utilities, facility systems, process support systems, bioprocess manufacturing systems, packaging equipment, and process and cleaning validation is desirable.
  • Demonstrated client development experience and excellent presentation skills
  • Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems, ability to read engineering documents, set priorities, and work on multiple projects simultaneously.
  • Experience building, managing, and leading teams
  • Experience with creating proposals and business development.
  • Experience with financial systems, project, and client administration
  • Strong leadership, verbal communication, technical writing, project management tools and word processing skills.
  • Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.
  • Project Management experience in managing scope, cost, schedule, quality and risk is required.
  • Excellent time management skills and ability to multi-task on simultaneous projects
  • Travel as required for client development and project execution
  • Displayed leadership in a consulting and service environment.
  • Willing and able to travel as necessary for project requirements to include but not be limited to : project installation and start-up activities, client meetings, company sponsored meetings, trainings, industry related seminars, forums, or conventions, etc.
  • BS Degree in Engineering or related technical degree
  • Our culture and commitment to our people is what sets us apart. We foster an environment of mutual respect, integrity, and unconditional interest in the individual and collective success of our professionals. Our model and entrepreneurial mindset offer a rewarding, challenging, and highly flexible path. As a Client Development Lead, Validation and Regulatory Compliance, you will build a meaningful and fulfilling career with the support of professional development resources and mentorships including our First Year Experience program, Individual Development Plans, and Career Path resources and tools. You will be surrounded by exceptional talent who will support your development as both a world-class engineer and a highly effective leader.

    The approximate pay range for this position is $160k - $230k. Please note that the pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to background, knowledge, skills, and abilities as well as geographic location of the position.

    Barry-Wehmiller is an equal opportunity employer. M / F / D / V This organization uses E-Verify.

    Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and / or skills assessments.

    Barry-Wehmiller is an equal opportunity employer. M / F / D / V This organization uses E-Verify.Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and / or skills assessments.

    Company : Design Group

    [job_alerts.create_a_job]

    Client Development Lead Validation and Regulatory Compliance • Santa Ana, CA USA

    [internal_linking.similar_jobs]
    Compliance Director

    Compliance Director

    TradeJobsWorkForce • 92702 Santa Ana, CA, US
    [job_card.full_time]
    Compliance Director Job Duties : Accomplishes compliance human resource strategies by determining acco...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Wastewater Systems Compliance Manager

    Wastewater Systems Compliance Manager

    California Water Service • Commerce, CA, United States
    [job_card.full_time]
    The Wastewater Systems Compliance Manager reports to the VP of Water Quality & Environmental Affairs and will be responsible for overseeing all of California Water Service Group (CWSG) Wastewater a...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    AVP Technology Ecosystem & Partnership

    AVP Technology Ecosystem & Partnership

    Pacific Asset Management, LLC • Newport Beach, CA, United States
    [job_card.full_time]
    Strategic Influence : Ability to shape and communicate a clear technology vision that resonates across all levels of the organization. Technical Mastery : Demonstrated depth and hands-on experience ac...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Contracts Specialist - Negotiation & Compliance

    Senior Contracts Specialist - Negotiation & Compliance

    Babcock Power • La Palma, CA, United States
    [job_card.full_time]
    A leading company in the power generation sector seeks a highly experienced Sr Contracts Specialist for its La Palma, CA office. The role entails reviewing, negotiating, and drafting contracts while...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Paralegal (Compliance / Regulatory Affairs)

    Paralegal (Compliance / Regulatory Affairs)

    PrideStaff • Lakewood, CA, United States
    [job_card.full_time]
    Compliance / Regulatory Affairs).We're looking for a Paralegal who's open to working in a Regulatory Affairs Coordinator capacity for a global distributor in Lakewood, CA.This is not a traditional ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    District Director, EEO and Compliance

    District Director, EEO and Compliance

    North Orange County Community College District • Anaheim, CA, United States
    [job_card.full_time] +1
    District Director, EEO and Compliance.District Director, EEO and Compliance.Monday - Friday, 8 : 00 am - 5 : 00 pm (However, some flexibility such as evenings and weekends will be required to meet the ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Vice President, Compliance Officer

    Vice President, Compliance Officer

    PIMCO Ltd. - Pacific Investment Management Company • Newport Beach, CA, United States
    [job_card.full_time]
    PIMCO is a global leader in active fixed income with deep expertise across public and private markets.We invest our clients' capital across a range of fixed income and credit opportunities, leverag...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Water & Wastewater Client Leader - Growth & Strategy

    Water & Wastewater Client Leader - Growth & Strategy

    Kennedyjenks • Pasadena, CA, United States
    [job_card.full_time]
    A leading engineering consultancy is seeking a Client Service Director to manage and expand their water and wastewater practice. This senior role requires a proven track record in client relationshi...[show_more]
    [last_updated.last_updated_30] • [promoted]
    VP, Risk Adjustment & Quality

    VP, Risk Adjustment & Quality

    HJ Staffing • Huntington Beach, CA, United States
    [job_card.full_time]
    In this role, you will oversee the complete lifecycle of risk capture including prospective, concurrent, and retrospective workflows while ensuring our organization maintains high performance in CM...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Hybrid Litigation Associate : Trial & White Collar Defense

    Hybrid Litigation Associate : Trial & White Collar Defense

    Talent Search PRO • Orange, CA, United States
    [job_card.full_time]
    A leading legal recruitment firm is seeking qualified associates with 3 to 6 years of litigation experience to join their high-profile litigation practice. The ideal candidates will have hands-on ex...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Global GMP Lead Auditor Quality Compliance & Audits

    Global GMP Lead Auditor Quality Compliance & Audits

    UL Solutions • Brea, CA, United States
    [job_card.full_time]
    A global safety science leader is seeking a Lead Auditor specializing in GMP Quality Audits to perform assessments in various manufacturing settings. The ideal candidate will have a relevant degree ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Analyst / Associate Client Solutions & Investment Analytics

    Analyst / Associate Client Solutions & Investment Analytics

    LGBT Great • Newport Beach, CA, United States
    [job_card.full_time]
    A leading financial services firm is seeking an Analyst or Associate in Newport Beach to join the Client Solutions & Analytics group. This role involves generating actionable investment insights and...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Strategic CAAS Client Growth Director

    Strategic CAAS Client Growth Director

    CliftonLarsonAllen • Pasadena, CA, United States
    [job_card.full_time]
    A national accounting and consulting firm is seeking a Client Relationship Director to expand its CAAS practice.This role involves maintaining existing client relationships and developing new ones ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Partner

    Partner

    Law firm • Newport Beach, CA, United States
    [job_card.full_time]
    Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive features.This range is provided by Law firm. Your actual pay will be based on your skills and experience — talk ...[show_more]
    [last_updated.last_updated_30] • [promoted]
    District Director, EEO and Compliance

    District Director, EEO and Compliance

    InsideHigherEd • Anaheim, California, United States
    [job_card.full_time] +1
    District Director, EEO and Compliance.North Orange County Community College District.Monday - Friday, 8 : 00 am - 5 : 00 pm (However, some flexibility such as evenings and weekends will be required to ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Civil Defense Litigation Associate ($125,000-$180,000)

    Civil Defense Litigation Associate ($125,000-$180,000)

    Jasurda Group • Costa Mesa, CA, United States
    [job_card.full_time]
    Civil Defense Litigation Associate.Draft and respond to written discovery, including interrogatories, requests for production, and requests for admission. Prepare and argue motions and attend court ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Analyst, Client Solutions & Analytics (Fixed Income)

    Analyst, Client Solutions & Analytics (Fixed Income)

    LGBT Great • Newport Beach, CA, United States
    [job_card.full_time]
    A global investment management company is seeking an Analyst / Associate for their Client Solutions & Analytics group.The candidate will support portfolio analysis, develop presentations, and assist ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Consulting Director, Regulatory Analyst (Utilities / Power / Renewables)

    Consulting Director, Regulatory Analyst (Utilities / Power / Renewables)

    ERM • Pasadena, CA, United States
    [job_card.full_time]
    Consulting Director, Planner Regulatory Specialist.Join our global consulting firm to lead environmental regulatory and permitting activities for large‑scale capital projects in California.As a sen...[show_more]
    [last_updated.last_updated_30] • [promoted]