QA Disposition Manager
Title: QA Disposition Manager
Client: Major Pharmaceutical Firm
Contract Duration: 6 Month assignment
On-site in Exton, PA
One of Real Staffing's Major Pharmaceutical clients has just released an opening for a Quality Assurance Disposition Manager on a 6 month contract assignment. The role is located on-site in Exton, PA, and this location is well known for their positive work culture and environment.
This position has responsibility for performing Batch Disposition activities for Global API and US
Drug Product, Finished Goods in accordance with their Registered Approvals or Marketing
Authorizations, their Manufacturing Authorizations, Global Quality Standards and
Procedures, and the principles and guidelines of current Good Manufacturing Practices.
- Assists with the prioritization and coordination of batch release activities, to prevent supply disruption.
- Review of batch record information from Contract Manufacturers/ Suppliers, and compilation of batch documentation for review according to company requirements and SAP inspection plans.
- Transfer needed information from Contract Manufacturers/ Suppliers batch documentation into systems e.g. LabLIMS and SAP/BPR
- Prepare and review batch documentation for release, including upload of batch certificates to the repository.
- Archive batch documentation according to company and customer requirements.
- Perform Technical Release of products in SAP/BPR based on release certificates from Contract
- Manufacturers/ Suppliers
- Support other functions as needed with e.g. PQR preparation, deviations, change controls, and
- Maintenance of product lists and Quality relevant SAP master data.
- Provides other support/input as needed to ensure the effective oversight of Contract
- Manufacturers/Suppliers and compliance of OncESSM procedure/processes with company requirements, and GMP.
PREFERRED SKILLS AND KNOWLEDGE
- Knowledge and understanding of relevant pharmaceutical regulations in US, Japan, Europe and relevant markets.
- Knowledge and experience of Bio-Pharmaceutical Manufacturing (in particular small molecules and Oncology products)
- Knowledge of LEAN and Continuous Improvement tools.
- Leadership (Vision, strategy and business alignment, people management, communication, influencing others, managing change)
- Ability to make risk based Quality decisions impacting products and services within scope of oversight, and prioritize accordingly.
- Ability to elevate organizational performance by partner with stakeholders.
- Ability to operate within and across multiple regions, and cross functionally.
- Decision-making and Autonomy (The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-soliving)
- Responsible for day to day disposition decision with CMO/CTL.
- Responsible for escalating any issues identified during review of manufacturing/analytical information provided from CMO/CTLs.
- Interaction (The span and nature of one's engagement with others when performing one's job, internal and external relationships)
- Key Stakeholders include: OncESSM ESQL, GMS, Regulatory Affairs, Supply Chain,
- Commercial organizations, R&D teams, Procurement, Internal Manufacturing sites,
- Manufacturing Sciences, Quality Systems and Compliance.
- Interacts with stakeholders, regulators, industry peers and other quality units.
- Innovation (The required level of scientific knowledge, knowledge sharing, innovation and risk taking)
- A firm grasp of industry, scientific and regulatory trends, understands market conditions, and develops strategies to evolve the company's regulatory profile to become the model for the industry.
- Demonstrates an understanding of priorities, objectives, and project timelines.
- Complexity (Products managed, mix of businesses, internal and/or external business environment, cultural considerations)
- Accountable for supporting disposition activities at CMOs or CTLs for the company'sOncology and Small Molecule commercial products.
EDUCATION AND EXPERIENCE REQUIREMENTS
- Bachelor's Degree in Pharmacy, Chemistry, Biology, or related discipline
- Minimum 6 years of QA/QC experience in the pharmaceutical industry
- Demonstrated teamwork, initiative, and problem-solving skills
- Fluent in English language oral/written communication skills
- Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
- Analytical Skills - ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
- Teamwork - ability to establish professional relationships and rapport with internal and external peers and higher-level management
- Proactiveness - ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
- Regulatory Understanding - broad based knowledge of domestic and general knowledge of international regulations associated with manufacturing and packaging
- Core Competencies / Skills
- Critical Thinking
- Digital and analytical skills
- Investigation and problem solving
- Good communication skills engaging stakeholders: site, business, network, company, regulators
- Risk identification, evaluation and management
- Continuous improvement
- Leadership Behaviors
- Enterprise thinking, finding innovative ways to improve compliance and process
- Elevates capabilities of the organization
Sthree US is acting as an Employment Business in relation to this vacancy.