Great opportunity with our Pharmaceutical client in Baltimore, MD!
Provide management, leadership, and direction to Quality Operations personnel located at the Baltimore facility.
Develop and oversee the implementation of the quality systems required by the CGMPs for the Baltimore site. Propose and implement revisions to existing programs (continuous improvement). Assure that the Baltimore site remains compliant with global regulatory requirements and expectations and that the site is inspection ready.
Serve as the Quality contact for the site with regards to interactions with regulatory agencies and business partners. Leads regulatory inspections and partner audits. Contacts regulatory agencies for field alerts, recalls, etc.
Serves as the Gliadel point of contact for Quality and drives strategy, sets direction with respect to LCM and coordination of global Brand efforts, participates in Brand Team (along with Established Products, Global Regulatory Affairs, and Legal)/
Authors and approves Quality Agreements for local partners, establishes and builds relationships and assists with technical questions, repatriations, and assesses Quality impacts and implications of various business scenarios across individual or multiple markets.
Create organizational design that supports the Baltimore site needs while maximizing the effectiveness of the Baltimore Quality Operations unit. Coach and develop direct reports. Create and execute succession plan for Baltimore Quality Operations organization. Create and sell the Vision and Strategy for Baltimore Quality Operations. Translate the vision and strategy into action and measure outcomes.
Requires 7-10 years experience in a Quality role.
Experience leading Quality Operations at a senior management/leadership level with proven ability to see the “big picture”.
Advanced degree (or BS degree with equivalent experience) in scientific study (i.e., Chemistry, Biology, etc.).
15+ years of progressively responsible QA/QC in the pharmaceutical industry with strong track record of regulatory compliance.
Ability to work independently within a self-sufficient organization yet is able to see the big picture.
Thorough knowledge of cGMPs and regulatory standards including their current application and interpretation by the FDA, EMA, PMDA and other worldwide regulatory agencies.
Experience working with pharmacopeia; USP preferred.
Experience in facilitating and supporting regulatory inspections (FDA, EMEA, PMDA, ANVISA, etc.).
Strong understanding of manufacturing, sourcing, materials management, QA and QC.
Demonstrated ability to innovate and develop new approaches to quality assurance, quality control and compliance acceptable to the regulatory agencies.
Knowledge of system and process validation, including validation for computerized systems.
Knowledge of total quality management systems and statistical process control.
Strong interpersonal relationship skills; as well as excellent communication skills (oral and written).
Proven people management and development skills. Ability to understand what’s necessary to run the business; assess employee performance, organizational design, mentorship, accountability, provide guidance on employee development to address gaps and future staffing needs of the organization.
Prior plant management experience preferred
Very competitive compensation & benefits package!