Senior Manager, Quality Assurance Investigations and Improvements
Will have primary responsibility for the investigation of manufacturing, packaging deviations for a high volume commercial facility.
Assure root cause for each occurrence is correctly determined and corrected
Develop / utilize efficient method of tracking and trending of plant wide deviations.
Develop / implement meaningful metrics to monitor deviation levels and improvement activities.
Assure all deviations are resolved meeting FDA committed to timelines.
Interact with Production Planning assuring all deviations are resolved meeting supply chain needs.
Lead Quality Improvement teams based on findings from internal audits, and FDA inspections.
Assure systems are in place and functioning to meet all regulatory requirements.
Develop, maintain and mentor QA professionals
Assure Corporate Management is informed of any potential compliance issue at the facility.
Support audits as necessary.
Number of exempt employees supervised: up to 10
The position requires a four year college degree in a scientific discipline or equivalent and 8-10 years pharmaceutical experience; including supervisory / management roles in an oral solid dosage facility. A certified Quality Engineering (CQE) diploma or statistics preferred.
This position requires an individual expert in cGMP’s, plant floor operations and a solid understanding of manufacturing / packaging operations. Individual should have a proven track record for determining root cause analysis and providing reasonable cost effective solutions to issues identified. Must have strong understanding of FDA inspectional techniques and the relational skills to develop and mentor a department as well as interacting with other professionals and management in the organization. Excellent written and verbal communication skills and the ability to make critical and timely decisions
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.