Responsible for compliance with internal procedures, local, state, and federal regulations at Nephron Pharmaceuticals Corporation and Nephron 503B Outsourcing Facility.
Lead and support the formation, execution, and implementation of compliant production projects and initiatives.
Consistent collaboration with all department heads to ensure that organizational strategies are developed and applied.
Provide leadership and strategic direction for Production Personnel.
Reports directly to Chief Operating Officer
Performs and assists with additional work duties or responsibilities as assigned or apparent.
Primary Accountabilities:
NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents' performance objectives as outlined by the incumbents' immediate supervisor or manager.
Expected to develop and execute integrated strategies that help realize the organization l s purpose and drives responsible growth.
Partner with functional leads to develop integrated plans aligned with the Quality System and promotes cGMP compliance.
Support the Production team to ensure that processes comply with internal procedures and regulatory requirements.
Create and assist with projects to continuously improve the Quality System.
Identifies resources needed and assigns individual responsibilities for various projects.
Follow procedures to ensure change control of documents, equipment/process, materials, investigations, CAPAs, and audits are initiated, recorded, and implemented.
Aid and support for an effective Production team.
Participate and conduct inspection readiness activities.
Present progress reports or presentations at appropriate intervals to multiple levels in the organization to support remediation monitoring to identify process gaps, validate compliance levels, and map processes.
0 Ensures project documents are complete and current, with all documentation performed as necessary.
Maintain strict company confidentiality.
Team player with the highest of personal values and ethical standards.
Ensures cross-functional alignment and accountability.
Salary range: Based on experience
0 Hours of work: 40 hours per week or as needed based on company demand.
Knowledge, Skills & Abilities:
BS or BA Degree required; Engineering or Business Management degree preferred.
Minimum of ten years of project management experience including a minimum of five (5) years of leadership experience
2-5 years of experience with MS Word, Excel, and PowerPoint preferred.
Excellent written and oral communication skills.
0 Ability to work independently and be dependable.
Ability to manage, train, motivate, and discipline employees.
Technical writing skills required.
Strong attention to detail.
Incumbents are required to wear specified protective equipment as necessary.
The ability to identify work elements in detail, and develop work standards, and work method improvements; develop procedures, and forms to effect method improvement and work simplification.
Specific expertise, skills, and knowledge of project management gained through education and experience.
A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.
The ability to take strategic objectives and accept accountability to drive results through effective actions.
The ability and willingness to change direction and focus to meet shifting organizational and business demands.
The ability to set clear targets and use performance measures to assess risk and opportunities in order to effectively manage the assets of the business.
The ability to create and contribute to an environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
The ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals.
The ability to manage a multitude of resources and to be accurate and current with data and information.
Position requires lifting (up to 40 lbs.), vision (20/20), standing (10%), sitting (40%), walking (50%), talking, typing and hearing.
