Program Management Consultant

About Lois Oler:

Over 15-years of collective Medical Device, MedTech and Pharmaceutical experience. I have extensive experience directing large-scale quality and compliance efforts to uphold medical device and pharmaceutical quality and business continuity. Accustomed to managing large-scale programs that require executive foresight and an advanced knowledge of leading-edge industry, product, and quality practices to inform continuous improvement efforts. Authentic and decisive leadership style capable of upholding government, international, and domestic standards of safety, quality, and compliance for medical device design and manufacturing.

Lois excels at building consensus-driven relationships with senior-level stakeholders to inform product, site, and segment objectives. Valued for planning and leading key quality and compliance strategies based on key business imperatives, operating models, and industry requirements.

Role Highlights:

• COVID Program Manager, where we worked with Astra-Zeneca, Johnson & Johnson, Pfizer and Moderna, to implement the COVID-19 Vaccine globally. Our project was also highlighted on the US Customs and Homeland Security website, announcing the breakthrough taking one step closer towards patient supply.
• BioTech Program Manager, where we implemented a program to manufacture and produce human organ transplants.
• EU MDR Program Manager, where we successfully filed 9-Technical Files within a 3-month period and achieved our EM CE Mark with the right to sell, including the SwissExit and Brexit strategies.

Credentials:

• Six Sigma Black Belt (SSBB)
• Project Management Professional (PMP)
• Certified Quality Manager – Organizational Excellence (CQM-OE)
• Member of ASQ (American Society of Quality) since 2015.

LinkedIn Profile: https://www.linkedin.com/in/lois-oler-4a9b0740/

Email: Contact Lois