The Quality Assurance Drug Product Manager / TL will be primarily based in Sterile Product Manufacturing building (SPM) and the Sterile Product Support (SPS) building and will provide general oversight to MQA personnel and Floor QA personnel.
Manage process improvement project portfolios in Operations with direct reporting responsibility to Quality and Process Improvement management team; employ Lean Six Sigma project management standards, including creation of charters, scope, goals, and benefits of process improvement initiatives.
The purpose of this position is to drive the strategic direction of data quality technology solutions including related reporting and analytics capabilities, as well as to lead the team of business systems consultants designing and supporting those solutions. He or she will design and execute operational capabilities around the selected toolset, will establish a program with measurable performance metrics.
Review all Medicare and other episodic payers clinical records at the local level to assure appropriate documentation for reimbursement. This review includes verification of appropriate documentation, quality of care provided, visits utilization, appropriate contacts with physicians, adherence to the care plan, and evidence of communication between disciplines.
Lead and facilitate performance improvement projects using a combination of improvement methodologies, including Lean and Six Sigma; partner with stakeholders in the development of project plans that align with standards set forth by accreditation/regulatory agencies and with the Annual Business Plan.
In this role, the selected candidate will provide quality oversight of Companion Diagnostic (CDx) and Diagnostics development programs at third party diagnostic sites and liaise with Clinical QA/Dev Ops as required in order to ensure the CDx programs meet device regulations and are suitable for use in Pfizer sponsored clinical trials.
In this role, you will be responsible to analyzes, plans and implements process improvement and quality (such as six sigma initiative) recommendations. Evaluates and models existing processes and identifies improvement options.
Evaluate, analyze and report on product and process quality performance to established quality goals.Monitor product quality through inspection testing and auditing. Establish statistically sound programs for sampling and process validations.
In this role, you will be responsible for developing a Quality Assurance Program to ensure compliance is maintained with federal, state, county contracts, grants, accrediting bodies, labor laws and documentation retention requirements.
Designing and implementing Quality systems which comply with Corporate Policies, training staff and key personnel in order to attain strategic objectives, along with providing management quality trend information to aid in achieving these objectives.
In this role, the selected candidate will define and implement quality improvements to improve operations and unit cost; investigate and analyze quality problems, recommending solutions and following up to ensure corrective actions are put in place.
In this role, you will coordinate with product management to address conflicts identified between product expectations and the documented product specification must be addressed and updated in the spec and/or audit criteria.