OCT Consulting LLC is a boutique management consulting company that provides support to Federal Government clients. We provide consulting services in the areas of Strategy, Process Improvement, Change Management, Program and Project Management, Acquisition/Procurement, and Information Technology.

Responsibilities and Duties

OCT Consulting LLC is recruiting on behalf of a federal client for a Lead Supply Chain Specialist who will

serve as the subject matter expert on medical device supply chain management and provide authoritative, sound, and evidence-based information to the senior officials to ensure the sustained availability of medical devices during times of calm and public health emergencies, both natural and man-made.

The following are typical duties and responsibilities of the Lead Supply Chain Specialist:

• Provide leadership, oversight, and coordination for the Center in matters relating to availability of medical devices and their supply chains.
• Support champions in the management of initiatives through leadership, meeting management, and project management, including risk management.
• Utilize expert supply chain and logistics knowledge, risk mitigation expertise, and scientific and regulatory experience to collaboratively advance the RSCP’s medical device supply chain program and serve as an expert on the Center’s cross-functional supply chain team to address challenges to assure safe and effective medical devices are broadly available.
• Evaluate the causation of various supply chain shocks and develop and share mitigation strategies across the Center and Agency, as well as with industry, suppliers, contract manufacturers, distributors, and other stakeholders to stem potential disruptions.
• Provide leadership to cultivate formal and informal partnerships with medical device manufacturers, suppliers, carriers, scientific associations, organizations, and societies, patient-focused, foreign stakeholders, to include international producers and government entities, and other U.S. government officials at the federal, state, and local levels regarding supply chain concerns and regulatory impact of disruptions.
• Counsel and train members of the team, explain critical and significant supply chain and technology concepts, establish methodologies, procedures, guidelines, and policies.

• Lead the timely analysis, solution development, and resolution of newly identified issues
• Draft recommendations to address supply chain vulnerabilities and risks, that could lead to potential disruptions
• Collaborate with colleagues to continuously evaluate the performance and impact of the Center’s supply chain program and research new and emerging technologies to enhance data collection
• Draw upon Center experts' comprehensive knowledge of medical devices, product history, and related matters to anticipate and identify supply chain issues, and to ensure that the project team is aware of these problems and addresses them
• Explore and develop new ways of resolving issues and building consensus among appropriate subject matter experts, managers, and where appropriate, industry officials, and external professional association representatives; ensures that these issues are identified across the Center are addressed in a timely and effective manner.
• Conduct expert technical reviews of precedent-setting professional studies, research, and/or analysis
• Help support the development of policy around supply chain oversight

• Interpret and apply existing policy, setting precedents that affect internal and industry program activities and the supply chain of regulated products
• Compare and contrast current and proposed policies to formulate strategies for CDRH to effectively address medical device supply chains
• Lead the development of supply chain visualizations for a wide range of medical device products to determine the vulnerabilities, risks, alternative products, and potential mitigations.
• Work with manufacturers to extract supply chain data and conduct supply chain network analytics, putting different data together and extracting insights from data from multiple sources.

MANAGEMENT DUTIES:

The Lead Supply Chain Specialist is a non-supervisory position but considered a senior position and collaboration is a key component to ensure goals and mission requirements are met.

Requirements

CANDIDATE QUALIFICATIONS:

Candidates must have professional experience and qualifications commensurate with the duties of the position. Qualified candidates should possess:

• Multiple years of Supply Chain Management experience inside the federal government or in the private sector
• Supply chain experience with public health or within the medical devices supply chain arena is highly desired
• Global supply chain experience is highly desired
• Must possess a strong background in the Supply Chain Management
• Experience in evaluating, as well as enhancing medical device supply chains across large and complex scientific, health care, and regulatory organizations, to mitigate vulnerabilities and potential disruptions
• Experience as a strategic advisor with the ability to engage, build, and sustain relationships with internal and external stakeholders
• Experience establishing strategic metrics and milestones centered on supply chain resiliency

• Experience working in a regulatory environment (for example, FDA medical device approvals), either in the public or private sector
• A comprehensive understanding of the supply chain management and operations process from strategic sourcing and procurement through distribution
• Ability to lead and work collaboratively with a diverse cadre of colleagues and stakeholders in a continuous quality improvement environment.

EDUCATION:

Certification as a Certified Professional in Supply Chain Management (CPSM) (desired)

• Certification as a Certified Professional in Supply Chain Management (CPSM) (desired)

ADDITIONAL INFORMATION:

• One year probationary period may be required
• Background and/or Security investigation required.
• All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
• This is a confidential filing position, subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. If selected, the employee must complete ethics requirements and file an annual financial disclosure report (OGE-450 form). For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office website

Benefits

BENEFITS:

The position includes competitive compensation and a full suite of benefits:

• Medical, Dental, and Vision insurance
• Retirement savings 401K plan provided by an industry leading provider with 3% employer contributions.
• Paid Time Off
• Life Insurance, Short- and Long-Term disability benefits
• Training Benefits

COMPENSATION:
An attractive compensation package will be offered based upon background and experience, and commensurate with the FDA guidelines, to include starting salary of $126,233 to $165,000.

Note: This position is being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here. This is a term-limited position that is not anticipated to exceed four years.

ABOUT OCT Consulting LLC:

OCT Consulting LLC is a certified SBA 8(a), minority owned, small, disadvantaged business providing professional services and Information technology solutions to the federal government and commercial clients. Founded in 2013, we bring the advantage of agility in operations along with a management team with a track record of leading successful engagements at major federal government agencies.

OCT is committed to a diverse and inclusive workplace. OCT is an equal opportunity employer and does not discriminate on the basis of race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.