Sr Mgr Quality

Endo•Hobart, NY

About The Position

The Senior Manager Quality Assurance oversees, manages, and ensures the successful day-to-day operations of Quality Assurance department including QA Operations (batch review), QA Label Control (label review), QA Document Control, QA Release, and Quality Engineering (Deviation, APR/AR, Change Control, CAPA, and KPI Metrics). The Senior Manager ensures the success of the teams by oversight and development of the Managers, Supervisors and Individual Contributors.

Requirements

Education: Bachelor’s or Master’s Degree in Chemistry, Chemical Engineering, related science or equivalent combination of Education, Experience and Competencies.
Experience: Minimum of 10 years’ experience in the pharmaceutical or similarly regulated industry, preferably in a Quality Assurance, Quality Control, Regulatory or Validation related position.
Minimum of 5 years in a Management or Supervisory position.
Knowledge of regulatory environment.
Excellent oral and written communication skills.
Excellent organizational skills.
Proven decision-making ability.
Proven personnel development ability.
Good presentation skills.
Experience in a DEA regulated environment is highly desirable.

Nice To Haves

Continuous improvement mindset.
Assertive assurance of quality throughout all operations within the facility.
The ability to constructively work with colleagues when a Quality concern is in conflict with short-term business desires to successfully conclude the issue at hand to the best business advantage (both short- and long-term) without sacrificing the quality of work or the Quality Culture at the site.
Extensive knowledge of FDA regulatory requirements applicable to pharmaceuticals.
Applies GMP regulations and other international guidelines to all aspects of the position.
Provides overall departmental feedback to Site Quality Director.
Able to work with the goals and objectives of the Site Quality Director and translate them into actionable work for staff to meet those goals and objectives.
Able to create and maintain highly functioning teams, cohesive, striving for common and individual goals, in a positive atmosphere for all employees.
Able to coach and mentor more junior employees to success.
Able to read, comprehend, and make appropriate alterations to documents such as batch records, quality agreements, SOPs, etc.
Actively takes the lead in ensuring GMP compliance for the company.
Sets strategy in investigations and CAPAs, as necessary. Ensures follow up.
Communicates with contractors and internal manufacturing/technical groups regarding compliance and quality issues (i.e., batch documentation, investigations, timelines and data related issues).
Participates and/or leads meetings, to provide input on timelines, potential compliance issues and other related Quality Assurance activities.
Able to indirectly manage performance of people through direct reports.

Responsibilities

Performance of Functional Area & People Are Appropriate for Business Needs
Staff Aligned to Organizational Goals: Translates the corporate vision, values and goals into day-to-day activities and behaviors; guides and motivates others to take actions that support the vision, values and goals. Holds regular team meetings to ensure staff are kept in the loop.
Performance Managed: Manages employee performance by clearly defining job responsibilities and standards of performance; tracking progress against goals; providing clear, thorough, timely feedback; and addressing performance problems and issues promptly. Develops coaching partnerships with direct reports. Provides training and development plans. Generates team goals and manages yearly progress of goal completion. Provides reports with challenging assignments and opportunities to address their development needs. Provides continuous feedback and end-of-year performance review.
Change Leader: Acts as a champion for change. Encourages employees to question established work processes or assumptions; challenges employees to ask “why” until underlying cause is discovered; involves stakeholders in continuous improvement actions and alternatives. Develops, plans, and follows through on change initiatives. Accepts the ambiguity that comes with change activities.
Resources Allocated to Ensure Critical Priorities Are Met: Ensures money, technology, and staff are allocated to achieve optimal results.
Culture of Continuous Learning & Improvement: Anticipates talents, skills and knowledge that will be needed in the organization; delegates tasks and responsibilities to others to grow skills while at the same time managing risk and establishing appropriate controls.
Right People Selected & Onboarded: Ensures a clear and effective job description is developed prior to beginning recruitment efforts. Conducts thorough interviews that enable clear selection decisions; ensures onboarding processes drive rapid time to full productivity.
Communication: Creates an atmosphere in which timely and high-quality information flows smoothly up and down, inside and outside of the organization; encourages open expression of ideas and opinions.
Safe, Effective Product Releases Ensures the Quality Assurance groups successfully monitor the quality of all manufacturing and packaging activities including executing batch manufacturing and packaging records in accordance with specified timelines. Continually seeks ways to improve the Quality Culture of the site. Ensures the Quality Assurance groups successfully issue and control labels and labeling confirming that issuance is on time and accurate. Ensures the Quality Assurance groups successfully performs batch disposition activities to meet specified timelines. Ensures the batch disposition process is robust and continually seeks ways to improve the disposition process both in terms of effort expended, timeliness of disposition, and quality of work performed/quality of the disposition.
Effective, Efficient Quality System Ensures the timely review of SOPs, work instructions, investigations, corrective actions, change controls, technical documents, and the adherence to Quality Agreements, where applicable. Establishes meaningful goals and metrics for groups in conjunction with the Site Quality Director, and manages the performance to those goals. Ensures the development, documentation and implementation of standardized processes for key business functions. Develops quantitative techniques to monitor process performance. Evaluates effectiveness of SOP, identifies changes that would enhance the process, and ensures that all change control documentation is implemented. Identifies and implements ways to streamline and improve efficiency while maintaining process effectiveness. Challenges the way it has always been done. Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance. Identifies the impact of available technology on business processes and ensures that it is used to maximum advantage.
Investigations Reach Sound Conclusions and Effective CAPA’s are Executed Leads the team that provides Quality Assurance review and approval of deviations. Review includes the determination that deviation investigations are sound, meet current regulatory requirements and ensure product is safe and effective. Leads, manages and/or participates in the investigation of non-conformances and follow-up corrective/preventative actions in compliance with quality procedures, policies and regulations. Works with individuals performing investigations to ensure the process is handled with the appropriate level of detail. Works with the appropriate discipline to identify corrective/preventative measures necessary for each observation made for improvement and to align processes to consistently manufacture quality products. Reviews and approves investigation reports to ensure it contains the appropriate level of detail; and appropriate CAPA’s are identified.