Global Quality Specialist

Davita Inc.; Gaithersburg (MD); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in the healthcare sector seeks a Global Quality Specialist to manage Quality Systems for external suppliers in Gaithersburg, MD. The role entails ensuring compliance with regulatory standards, overseeing documentation, and collaborating with cross-functional teams to maintain high quality in product supply. Ideal candidates will possess a strong educational background in sciences and proven experience in a pharmaceutical environment.

Qualifications

• Strong understanding of cGMPs and quality systems.
• Ability to work cross-functionally and manage improvement initiatives.
• Experience in Quality Assurance or related field.

Responsibilities

• Responsible for Quality Supplier Management including Annual Assessments and Quality Agreements.
• Oversees Quality reviews and approval of cGMP documentation.
• Collaborates with other Quality professionals to ensure compliance.

Skills

Quality Systems

Problem Solving

Communication

Project Management

Negotiating Skills

Education

Bachelor's degree in a science / technical field

Masters Degree in Quality Assurance/Regulatory Affairs

Job description

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.



Job Title: Global Quality Specialist



Location(s): Gaithersburg, MD





Job Summary:

• The incumbent is responsible for the Quality management of assigned External Suppliers within the API, DS, Cell Bank, Formulation & Packing (F&P), Vaccine, for Critical Material Supplier (CMS) . They are responsible for all Quality activities that directly support execution of Quality Management of Suppliers for assigned suppliers. This includes, but is not limited to, the Quality System oversight and/or performance of the following activities: change control, product quality complaint and deviation investigations, quality issue management and escalation, product release, Quality Agreements (establishment and maintenance) between AZ and External Suppliers and between EQ and AZ Operations Sites. Within the External Quality (EQ) organization the job holder is responsible for the oversight and ownership of Quality System(s). They will support the Quality Professionals involved in Quality Supplier and Product Supply Chain Management within the assigned categories. In addition, the preparation and submission of periodic Supplier Quality Assessments, Regulatory Agency interactions and serving as Quality leaders on NPI, new supplier introductions, In Licensing, strategic sourcing projects, process optimization and product transfer projects, as these relate to Quality Supplier management, are within the scope of this role. Regulatory Agency interaction includes preparation for, and management of, Regulatory Agency inspections at External Suppliers and AZ sites (when External Suppliers are assessed). In addition, incumbents having Quality Technical capabilities at a level to serve as subject matter experts (SMEs) fall within this job description. This position requires strong crossfunctional ways of working with nonQuality members across the EQ, GLF, ESM, PT&D, GTO, TOSI and RegCMC organizations.

Accountabilities:

• Responsible for Quality Supplier Management including but not limited to: Annual Assessments; Quality Agreements; trending and reporting of data; assessing, reviewing and improving quality systems at Suppliers; attendance at Quality and Business Review Meetings.


• Maintains a high level of understanding of relevant production processes and quality systems.


• Performs the Quality review and/or approval of the following cGMP documentation for their Suppliers:


• Change Requests


• Product Quality Reviews or Supplier Quality Review (DMS)


• CMC documentation (ERV) associated with changes or product establishment at Suppliers


• Development and technology transfer documentation, along with Director, Supply and Quality Systems, EQ


• Quality Investigations (Deviations, Product Quality Complaints)


• Validation Plans, Protocols and Reports


• Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems


• Responsible for quality issues escalation and resolution at the Suppliers, to ensure right product at the right time is delivered into the Product Supply Chain.


• Proactively ensures GMP and regulatory compliance during the planning, execution and closeout phases of projects at their Supplier(s).


• As a member of a Supplier Management team, responsible for supporting cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at their Supplier(s)


• Collaborates with, and influences, other PCO/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external Quality practices to identify innovative efficient and effective practices


• Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to EQ/AZ site leaders


• Collaborates in data analysis and report creation on quality metrics and key performance indicators


• Develops and maintains effective business relationships with Suppliers

Specific to the support and management of External Quality QMS, may be responsible for one or more of the following:

• Site Stability Management System.


• Manages quality data and records in relevant quality management support systems (e.g. Veeva Vault etc) as required.


• Assist in the production of, or contribution to, AZ quality documentation (including EQ/EQ SOPs, Q & C Manual Procedures, etc)


• Participates in EQ selfinspection program, auditing processes and procedures.


• Develops and maintains a high level of understanding of the technical production process and quality systems being utilized within the External Supply & Manufacturing (ESM) and External Quality (EQ) organizations


• Accountable for Quality decisionmaking; works directly with the Supplier Management leader and other team members to deliver objectives


• Ensures compliance with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring and consultation to the Supplier Management Team


• Provides functional direction as required.


• Planning for, supporting and participating in Regulatory Agency inspections of their Suppliers and AZ sites (regarding Quality management for supply of external materials to the Sites)


• As needed, perform Quality Audits within their technology area, as a Guest Auditor on the GQA lead audit team.


• Serve as EQ representative on Issue Management Teams


• Provide expert Quality input to NPI, Asset Strategy and/or Value Delivery projects. This includes identifying and assessing Suppliers, establishing Supplier's way of working with External Quality and supporting the Supplier through to regulatory approval.


• Liaise with Suppliers to ensure successful delivery of projects


• Make decisions and advise the Supplier Management Team regarding quality and pharmaceutical technology issues within their area of expertise.

Essential:

• Bachelor degree in a science / technical field


• such as Pharmacy, Biology, Chemistry or


• Engineering (Note: there may be specific additional requirements depending on the regulations in each country). Proven broad experience in either the pharmaceutical


• operations environment or pharmaceutical Quality Assurance role


• Strong demonstrated knowledge of cGMPs,


• Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.


• Excellent oral and written communication skills [English and local language(s)]


• Demonstrated experience working crossfunctionally and managing significant improvement initiatives (e.g. project management skills)


• Strong problem solving skills


• Strong negotiating/influencing skills


• Ability to work independently under his/her own initiative.


• Ability to travel nationally and internationally as required up to 25% of their time.

Desirable:

• Experience working in a PCO/PET organization or Lean/Six Sigma training.


• Multisite / multifunctional experience


• Proven experience in Quality Assurance or combination of Quality and Technical


• Masters Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.