Overview
Manager I, Quality Jobs in Minneapolis, MN at WestRock
Overview:
The Manager of Quality Assurance is responsible for the daily operations of the Quality Assurance team in a CDMO environment. This role will work with manufacturing and analytical operations to ensure that all activities are in compliance with company SOPs, cGMP/cGLP standards and FDA/EU regulations.
The Manager of Quality Assurance leads and mentors the quality team and is expected to be an integral part of the QA management team. This role will interact with clients and is responsible for successfully meeting client and departmental objectives and metrics.
This role is responsible for managing and coordinating the activities of the assigned team. Staff may include salaried and/or hourly non-exempt employees. Ability to work within a dynamic and fast paced environment.
Responsibilities:
Lead and facilitate a positive quality culture with all Cambrex employees and external partners.
Represents the department in external client and internal meetings, collaborates and cooperates to achieve cross-functional improvements and business goals.
Manage quality events (deviations, OOS records, change controls, and CAPA) in the QMS.
Creates departmental systems that foster a culture of quality and continuous improvement focused on value to the customer.
Ability to manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.
Ability to host and/or participate in internal, client and/or regulatory audits. Works with the site management in all areas to maintain a cGMP compliant facility in a constant state of inspection readiness.
Exercises judgment within defined procedures and practices to determine appropriate action for quality events.
Facilitates the development, implementation, and maintenance of procedures and policies to comply with FDA, EU, and ICH requirements applicable to site’s needs.
Recruits, trains, develops, and retains staff for the effective process of departmental operations.
Effectively resolves quality issues and concerns in a timely manner.
Drive customer deliverables in a timely manner by managing batch record review and execution, batch release, and reporting of analytical data.
Effectively manage and organize tasks to help drive the activities of others; while performing a variety of duties on schedule, with accuracy.
Creates strong and effective working relationships with Quality team, colleagues, and clients.
Qualifications / Skills::
Required Knowledge/ Skills/Abilities
Knowledge:
Experienced with review and approval of raw material, starting material, and finished product specifications.
Experienced with review and approval of batch records supporting small molecule API and/or finished solid oral dose drug product.
Experienced with review and approval of equipment and instrument validation as well as associated computer software validation.
Provide technical guidance for troubleshooting and investigating basic to complex issues with minimal direction.
Strong attention to detail, as well as time and resource management.
Strong personal and professional integrity and trustworthiness with strong work ethic.
Promote a safe environment for work.
Knowledge of global GMP and regulatory requirements related to the pharmaceutical drug development / manufacturing process.
Communicate clearly and effectively both verbally and in writing with internal and external clients.
Skilled in LIMS, MasterControl, Asset Management System, and Trackwise and/or other QMS software applications.
Skills / Abilities:
Strong analytical and problem-solving skills with proven ability to think strategically.
Demonstrated understanding of current FDA, EU and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
Effective team and interpersonal skills with the ability to work across numerous scientific and management disciplines.
Strong Computer Skills
Microsoft Suite proficiency
Qualifications:
Related BA/BS, required.
8+ years of relevant experience in a CDMO and/or pharmaceutical environment, preferably in Quality Assurance. Experience in clinical phase manufacturing is desired.
At least 2-3 years of experience in a leadership role directly supervising staff, preferably in pharma or biotech.
Title: Manager I, Quality
Company: WestRock
Location: Minneapolis, MN
