Alkermes is seeking an experienced individual to manage the Quality Control Data Review group based at the Wilmington, OH location. The Quality Control Manager oversees the daily operations of a group of compliance specialists and sets clear objectives around the execution and delivery of the QC data review workload. The Manager also ensures that all activities within the laboratory are performed in compliance with cGMP and internal written procedures and policies. The Manager is responsible for scheduling personnel resources to ensure that data review commitments are satisfied and communicates any difficulties to QC management. The Manager is accountable for the accuracy, integrity, and security of all results reviewed by the working group. The Manager measures progress, evaluates results, and takes responsibility for outcomes. The Manager also oversees compliance activities occurring within the department, ensuring that procedures and policies are compliant with current ALCOA+ principles.
- Supervise data review to ensure compliance with all applicable procedures, and timely completion
- Supervise laboratory investigations. Train data reviewers in the investigation process. Conduct troubleshooting and OOS investigations. Write or review investigation reports and other forms required by the investigation procedure. Implement CAPA as required.
- Leads specific aspects of a project and guide solutions for difficult problems. Identify best solutions based on project requirements.
- Ensure staff is adequately trained to perform job assignments. Execute training in accordance with written procedures, this would include but is not limited to training subordinate staff, perform training assessments, document training, assist in the preparation of training programs and curricula.
- Establish both group and individual goals; manage performance throughout the year by providing regular feedback. Perform annual performance appraisals.
- Participates in personnel decisions (interviewing, hiring, performance appraisals, promotion, disciplinary action, staff development, coaching and counseling) regarding subordinate staff.
- Discuss issues affecting staff, administer attendance policies for non-exempt employees
- Serve on special committees and project teams
- Review, evaluate, and approve SOPS, studies, change controls, and investigation reports
- Identify and report unsafe conditions within the laboratory
- Review technical reports and protocols originating in other departments
- Lead and support improvement projects
- Actively participates and contributes to the Laboratories mission and objectives. Facilitates dialogue and values input from others
- Deliver key business messages timely
- Works with department leaders to drive proactive compliance activities that promote consistent application of cGMP and ALCOA+ principles
- Ability to lead a Root Cause Analysis exercise either within the department or cross functionally for complex issues
- Capable of identifying the solution and follow through to implementation. Has the capacity to monitor the effectiveness of preventative measures and continuously improve. Articulate information clearly- verbally, written, group presentations
- Has the basic awareness to originate action to improve the performance and compliance within the Laboratory. Uses appropriate methods to identify opportunities, implement solutions, and measure the resultant impact on the operation of the Laboratory
- Excellent communication and documentation skills
- Appreciates the organizational vision/ site strategy and understands how the department and team related objectives are aligned.
- Develops objectives for team linked to site strategy and balance and achieve long term objectives with ongoing business demands and priorities
Preferred Personal Attributes:
- Communicates well in team settings. Seeks to understand others with diverse viewpoints and expertise. Places high priority on team and/or organizational goals. Begins to build strong relationships with stakeholders external to the Laboratory and takes advantage of these relationships to identify new opportunities.
- Continues to develop knowledge in relevant suite of products or analytical techniques and expands breadth of knowledge to include areas outside of direct function
- Demonstrates ability to generate and critique high quality / quantity of results from their individual team and present them coherently to an internal and /or external audience.
- Supportive and proactive approach to change in business demands.
- Understand departmental KPI's and their impact on site targets
- Takes input from others and stimulates open discussions
- Systematically analyzes successes and failures and uses them as learning experiences.
- Displays an appreciation for the end-goal and can anticipate problems and strategize solutions.
- Displays the appropriate amount of energy and concentration to "stay with the job" and displays the versatility to accommodate changes that might be required to the schedule to ensure all work activities are completed as required
- Recognizes and displays many of the hallmarks of a personally productive individual. Invests upfront in an appropriate amount of preparation for the task in hand, can eliminate the time-wasting activities, takes an ordered and disciplined approach to execution.
- Demonstrates empathy/ active listening and provide opportunities for individuals to talk freely in an open honest discussion setting
- Demonstrate diplomacy and tact to diffuse tense situations and presents arguments to support decision/ point of view
- Tailors message to audience to motivate and encourage
- Possesses the drive to achieve results and proactively seeks solutions when circumstances and goals are challenging and takes actions to overcome likely obstacles
- BS/BA in Chemistry or closely related field
- Strong leadership skills and managerial experience with a minimum of 5 years of laboratory management experience
- Minimum 10 years working experience in laboratory, preferrably in pharmaceutical or biotech industry