A project-oriented Quality / Compliance professional with 21 years industry experience looking for a position in a results-oriented company that seeks an ambitious and career conscious person, where acquired skills and education will be utilized toward continued growth and advancement.

  • Promote departmental growth and staff development. Experience in building effective teams to maximize results.
  • Comprehensive working knowledge of regulatory requirements including 21 CFR 820, 21 CFR 211, ISO 13485, ISO 9001, ISO 14971, ISO 11135, ISO 11737, ISO 10993-7, and CMDR.
  • Exemplar Global Certified, Lead Auditor of Quality Management Systems.
  • Considered as Subject Matter Expert (SME) on CAPA, Complaint Handling, and Auditing Demonstrated ability to effectively manage 1st, 2nd, and 3rd party audits (Internal, Customer, Notified Body, FDA, DEA, etc).
  • Excellent communication and interpersonal skills to interact directly with regulatory agencies including FDA and Notified Body.
  • Develop and implement Standard Operating Procedures (SOP’s) for Quality Management Systems.

Earned reputation as ‘Growth Accelerator and Profit Booster’ while managing P&L in global businesses in executive board-level roles in US, Germany, and UK. International experience as CEO/President working across 5 continents and 80 countries. As expert in major acquisitions, identifies opportunities, conducts due diligence, structures/negotiates complex deals, and smoothly integrates businesses. Known for designing innovative business models, spearheading process optimization, and cutting time to market to achieve sustainable profitability. From small-cap to large blue-chip operations, aggressively leads organic growth and turnaround situations, site relocations and complex strategic projects. Change Management Champion leading cross-functional teams within matrix organizations in:

  • Manufacturing
  • Medical Devices
  • Healthcare Solutions
  • Aerospace
  • Mobile Sector

Professional Product Manager and Sales leader with 10 years’ experience. Self-motivated and disciplined manager with the ability to resolve issues and mitigate risks. Prudent business acumen with focus on exceeding business goals and increasing market share and corporate brand.

  • Effective communicator capable of working cross-functionally to achieve consensus and drive results.
  • Builds and maintains long-term relationships with both internal and external stakeholders.
  • Demonstrates operations management skills, with proficiency in developing and executing business plans, overseeing marketing initiatives, and managing and training sales teams.
  • Highly structured, analytical, and detailed with the capacity to read and understand financial statements.
  • Prioritizes and executes within specified time-constraints and budgets.

Highly experienced executive with broad expertise building, growing, restructuring, and turning around company performance through financial, business, and operations solutions perspectives. Resilient and outcome-focused business strategist offering the strengths of a two-decade career designing transformational solutions and augmenting business value by overcoming a myriad of challenges in highly regulated industries, within mature and early-stage markets. Unique blend of executive-level strategies ranging from operations optimization, to business and market growth, to local and global team building, and business consulting. Understanding of international business cultures, regulations, and compliances, guiding organizations through political spectrum involved in starting a new business, expanding business reach or restructuring to mitigate risk and ensure sustainable revenue growth. Well-regarded and sought after for consistently delivering next-level results through:

  • heightened organizational needs assessment,
  • strategic planning,
  • precise execution,
  • and high-level alliance building.

Accomplished healthcare leader with 15 years of experience that includes managing quality programs, value improvement initiatives, electronic medical records implementations, and practice operations. Analyzes organizations’ current state and formulates strategy targeting population health, data-driven decisions, and patient engagement. Agent of change who provides innovative, cost-effective solutions to drive metrics-based improvements in patient health and satisfaction; gains physician and staff buy-in for changes and new programs. Builds strong relationships with cross-functional stakeholders and partners. Offers guidance to achieve organizational cohesion. Driving improvements to:

  • patient care/outcomes,
  • cost controls,
  • operational processes,
  • and patient experience.

Proven success in establishing operational excellence, building customer loyalty, and positioning startup company for profitable, sustainable, and scalable growth. Accomplished Director of Operations with eight years of instituting best practices and standard procedures for effective business operations, finance, programs, compliance, and human resources.

  • Customer-centric professional experienced in developing and deploying safe, effective programs and services that influence outcomes and retention levels.
  • Empowering leader skilled in building, engaging, and motivating high-performing teams across functional areas and geographic locations.
  • Tailor approach to address unique individual skill sets, experience levels, and situations.

Accomplished sales professional with strengths in account development, product education and customer service. Offer excellent presentation skills working with a diverse audience. Track activities, develop events, schedule appointments, and develop relationships. Listen attentively and actively; articulate ideas clearly and concisely. Known for honesty, follow-through, going the extra mile, and problem-solving. Analyze client needs and recommend solutions.

  • Solution Sales
  • Product Marketing
  • Vendor / Customer Relations
  • Customer Service & Retention
  • Customer Education
  • Product Launch / Introduction
  • Strategy Planning & Execution
  • New Business Development
  • Training / Mentoring
  • Revenue Growth
  • Quotations / Negotiations
  • Networking

Dynamic, dedicated, resourceful leader, with deep knowledge of managed markets, known for realizing department and company goals in increasingly demanding roles. Deliberate, determined, detail-oriented innovator, able to assess a situation, consider potential cause and effects, and develop a refined solution. Confident, engaging, principled, capable of motivating others to challenge the status quo, push themselves creatively, and generate novel ideas. Constant learner. Calculated risk taker. Recognized for sharing expertise with colleagues and mentoring staff.

  • Saved $2M by initiating RFP. Guided Sr. Leadership’s decision and renegotiated better terms with existing vendor.
  • Developed new launch framework for Hematology franchise, transforming launch strategy in Oncology Department.
  • Generated $20K+/- per account through a 40% increase in testing by educating physicians, practice managers, and staff.

Visionary operations executive within global supply chain and logistics. Possess deep industry experience and leverage LEAN Six Sigma methodologies to drive continuous improvement across the supply chain with the introduction of game-changing solutions and profit-building strategies in support of evolving corporate goals. Key contributor to company-wide efficiencies and perceived customer value. Transform supply chain and logistics into a smart, efficient, and profitable extension of company operations, leveraging state-of-the-art technologies and innovative solutions to solve supply chain problems, support services, and create exceptional customer experiences.

  • Certified Supply Chain Professional (CSCP)
  • Regulatory Compliance: AIB, OSHA, C-TPAT, FDA

20+ years’ global business leader—building, scaling, and leading high-growth organizations. Experienced in small to mid-sized biotechnology, chemical and plastics companies and partnering with CXOs to accelerate innovation, growth and profitability.

  • $12M P&L, 30+ Staff (Direct/Indirect), 3 Continents
  • Led 6 Technology Start-Up Spin-Offs and M&As
  • Monetizing New Technology and Product Solutions
  • Operations, Marketing, and M&A Leadership
  • Growth Strategist, CXO Partner, Change Agent
  • Frequent Speaker at Multiple Industry Events
  • Master of Business Administration (MBA)
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Phone: (610) 725-0290
Fax: (610) 975-0291
Email: info@ashtontweed.com

Ashton Tweed, Ltd.
565 E. Swedesford Rd.
Suite 214
Wayne, PA 19087

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