QA Compliance Specialist
Apply NowCompany: Mindlance
Location: Columbus, OH 43230
Description:
The Opportunity
Our location in Columbus, Ohio, United States currently has an opportunity for Quality Intelligence Project Manager.
Nutrition Supply Chain's (ANSC) QA organization is responsible for quality and compliance of Nutrition (AN) manufacturing and products.
This position will lead medium to large scale projects to support ANSC Quality Assurance strategic and compliance objectives. This position has the broad objective of supporting quality activities globally for AN Division QA, AN Affiliate QA and ANSC Manufacturing sites US and OUS.
This position will independently interface with affiliates, AN Division, AN manufacturing plants, R&D, Regulatory, Supply Chain and others. The position will successfully achieve the objectives through effective communication, change management, stakeholder management, strong interpersonal and presentation skills.
WHAT YOU'LL DO
Responsible for management and execution of multiple medium to large-scale projects that are
organized into the Quality Intelligence Program Management Office (QIPMO) associated with
regulatory requirements
Cross-functionally remediate current and future regulatory impact on the quality system
Ensure project scope is clearly defined: develop and manage project plans to meet deliverables
Manage cross-functional project timelines and follow up with project team members to ensure
timely completion of tasks
Address any resource constraints associated through data driven business proposals to meet
compliance requirements objectives and mitigate business risk
Responsible for identifying and managing critical project issues and risks, and timely
communication to senior leadership
Provide clear and consistent communication, both oral and written to all project stakeholders
on key project elements such as scope timeline, issues, etc
Understand and support AN Commercial QA and Quality Assurance Compliance organizations
and opportunities for improvements
Integrate key AQR/AN QA initiatives as appropriate, based on compliance risk and availability of
resources and business processes to support
Recommend and implement strategies and enhancements to improve efficiency
Develop and maintain effective KPIs that enable key success factors
Coordinate Quality Intelligence operations and business cycle updates
Accountability/Scope
The quality and compliance of AN products is a competitive advantage in the marketplace, and
any lessening of our standards or not meeting market requirements can have an adverse long-
term impact on our business. This position will work with limited supervision.
Education and experience you will bring:
Required
Minimum 5-8 years in a regulated nutritional food-manufacturing environment, preferably
pediatric or medical nutrition products, in a Quality, R&D, Project Management or Operations
function and good knowledge/awareness of food cGxP and nutritional regulations, Pharma
knowledge and experience is an advantage.
At least 3 years of management of complex projects or programs
Demonstrated ability in managing expectations on program requirements and deliverables
Demonstrated problem-solving abilities and knowledge in nutritional manufacturing controls
and quality systems
Well-developed interpersonal, communication and negotiation skills.
Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.).
Cross-functional/cross-divisional stakeholder management experience
Applicable technical knowledge/experience
Sound decision-making skills contributing to high levels of competence, confidence and
credibility
Experience dealing with international locations
Preferred
Master's degree
PMP certification
Ingredient expertise, process expertise, and formulation expertise in nutritional industry
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
Our location in Columbus, Ohio, United States currently has an opportunity for Quality Intelligence Project Manager.
Nutrition Supply Chain's (ANSC) QA organization is responsible for quality and compliance of Nutrition (AN) manufacturing and products.
This position will lead medium to large scale projects to support ANSC Quality Assurance strategic and compliance objectives. This position has the broad objective of supporting quality activities globally for AN Division QA, AN Affiliate QA and ANSC Manufacturing sites US and OUS.
This position will independently interface with affiliates, AN Division, AN manufacturing plants, R&D, Regulatory, Supply Chain and others. The position will successfully achieve the objectives through effective communication, change management, stakeholder management, strong interpersonal and presentation skills.
WHAT YOU'LL DO
Responsible for management and execution of multiple medium to large-scale projects that are
organized into the Quality Intelligence Program Management Office (QIPMO) associated with
regulatory requirements
Cross-functionally remediate current and future regulatory impact on the quality system
Ensure project scope is clearly defined: develop and manage project plans to meet deliverables
Manage cross-functional project timelines and follow up with project team members to ensure
timely completion of tasks
Address any resource constraints associated through data driven business proposals to meet
compliance requirements objectives and mitigate business risk
Responsible for identifying and managing critical project issues and risks, and timely
communication to senior leadership
Provide clear and consistent communication, both oral and written to all project stakeholders
on key project elements such as scope timeline, issues, etc
Understand and support AN Commercial QA and Quality Assurance Compliance organizations
and opportunities for improvements
Integrate key AQR/AN QA initiatives as appropriate, based on compliance risk and availability of
resources and business processes to support
Recommend and implement strategies and enhancements to improve efficiency
Develop and maintain effective KPIs that enable key success factors
Coordinate Quality Intelligence operations and business cycle updates
Accountability/Scope
The quality and compliance of AN products is a competitive advantage in the marketplace, and
any lessening of our standards or not meeting market requirements can have an adverse long-
term impact on our business. This position will work with limited supervision.
Education and experience you will bring:
Required
Minimum 5-8 years in a regulated nutritional food-manufacturing environment, preferably
pediatric or medical nutrition products, in a Quality, R&D, Project Management or Operations
function and good knowledge/awareness of food cGxP and nutritional regulations, Pharma
knowledge and experience is an advantage.
At least 3 years of management of complex projects or programs
Demonstrated ability in managing expectations on program requirements and deliverables
Demonstrated problem-solving abilities and knowledge in nutritional manufacturing controls
and quality systems
Well-developed interpersonal, communication and negotiation skills.
Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.).
Cross-functional/cross-divisional stakeholder management experience
Applicable technical knowledge/experience
Sound decision-making skills contributing to high levels of competence, confidence and
credibility
Experience dealing with international locations
Preferred
Master's degree
PMP certification
Ingredient expertise, process expertise, and formulation expertise in nutritional industry
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."