Senior Manager, Packaging Job in Saint Albans 05478, Vermont Us

Oversee the day to day operations of the Pharmaceutical Packaging Department to assure that product is produced in accordance with all corporate and federal quality, regulatory and safety requirements. The Senior Manager, Packaging is responsible for management of the 1st shift Packaging staff as well as overall responsibility for the Packaging processes for Lines K, J,  L, M, Z, H, and any new pharmaceutical packaging lines. The manager performs job functions in accordance with the Occupational Safety and Health Administration (OSHA) guidelines; compliance with the Standard Operating Procedures (SOP), Food and Drug Administration (FDA) regulations; Standard Test Methods (STM); and Current Good Manufacturing Practices (CGMP).

1. Monitor packaging lines, processes and production for quality, efficiency, and yield, and assure the ongoing improvement of each..  Assist in the establishment of packaging standards and monitor performance against these standards on an ongoing basis.

2. Prepare, review and monitor the Capital and Expense Budgets for the Packaging Department.  Implement the approved budget and prepare monthly updates to the forecast for the department.  Along with Engineering, ensure capital expenditures requests are well defined, monitored, executed (scope, budget, timelines) and documented.

3. Work with the Production Management Team to establish and manage annual departmental “SMART” goals and metrics and evaluate and execute corresponding continuous improvement intitiatves. 

4. Collaborate with Engineering, Production Support and Site OE to develop and implement packaging projects to improve quality and efficiency including the identification and implementation of new technologies.

5. Implement and/or revise Standard Operating Procedures as necessary and coordinate with supervisors and managers to ensure procedures match practice across all shifts on an ongoing basis.

6. Schedule jobs and employees’ hours to meet production demands and needs including market launches and ramp-ups.  Oversee and assure the reconciliation of payroll for 1st shift packaging employees and approve overtime, vacation and personal time in a manner which allows adequate staffing of packaging lines to meet the schedule.

7. Assure the timely completion of Batch Production Record reviews and reconciliation after production to enable accurate scheduling and cycle time goals to be met on a routine basis.

8. Through direct collaboration with Quality Assurance, lead or oversee deviations and investigations on batches out of tolerance and monitor trends associated with investigations and events.  Perform an annual review of all packaging investigations. 

9. Assure the assignment of effective corrective and preventative actions as a result of events, investigations and audits and monitor that these are carried out in a timely fashion.   Assure regular updates are provided as required by procedure.

10. Ensure the safety of employees in the Packaging Departments.  Oversee general housekeeping and maintenance of the facility and packaging equipment and materials.

11. Oversee the completion of Performance Evaluations on all Packaging employees and ensure adequate employee development plans are in place to meet future departmental needs.

12. Oversee the training of new personnel in Packaging procedures and compliance practices.  Provide ongoing process and product training to all line personnel as required.  Establish and maintain training curriculum for all levels of employees and generate the appropriate training tools, literature, presentations and documentation to maintain compliance with the training program.

13. Cover additional production areas or shifts in the absence of other managers.  Represent department in meetings or on projects for areas of responsibility as well as other production areas as necessary.  
KNOWLEDGE 
Must possess knowledge of packaging equipment, production floor management, computer and control systems, hardware, Microsoft Office Products (Excel, Word, PowerPoint, and Project) for scheduling, management, report generation and presentations.  Requires understanding of Standard Operating Procedures, Food and Drug Administration regulations and Current Good Manufacturing Practices.

SKILLS AND ABILITIES
Must possess strong leadership, analytical, numerical and reasoning skills along with well developed interpersonal skills with the ability to get along with diverse personalities by being tactful and mature.  Must be able to establish credibility and be decisive yet be able to recognize and support the organization’s preferences and priorities.  Must be results oriented with the ability to balance other business considerations.  Must be able to adhere to Company and Departmental policies and procedures as well as government regulations.

SUPERVISION
Position functions semi-autonomously.  Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION/EXPERIENCE
Minimum of a Bachelor's degree (or equivalent) and 5 - 10 years of experience.  However, a combination of experience and/or education will be taken into consideration.  BS preferred.

LICENSES/CERTIFICATIONS
None required

LANGUAGE SKILLS
Ability to read and interpret complex business and/or technical documents.  Ability to write comprehensive reports and detailed business correspondence.  Ability to work with groups of people such as other departments and communicate known concepts.  Ability to present to a group of departments.

MATHEMATICAL SKILLS
Ability to perform computations such as percentages, ratios, and rates. 

REASONING ABILITY
Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.  Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Typically sitting at a desk or table.  Intermittently sitting, standing, walking or stooping.  Periodic travel is required.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Normal office situation