Associate Director, Quality Assurance

Lsne Contract Manufacturing Bedford , NH 03110

Posted 4 weeks ago

Thrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement. If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference. Your work will matter and your contributions will be significant in these endeavors.

We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!

JOB SUMMARY

This position is responsible for the daily QA oversight of LSNE's commercial manufacturing plant. The role includes review and final disposition of batch records, releasing finished product and raw materials lots, reviewing / approving investigations and change controls, interacting with Clients concerning site specific quality issues, approving site CGMP documents, contributing to CGMP reports, and managing QA site staff as necessary to achieve these tasks. The incumbent will also be a key member of a cross functional team focused on harmonization and improvement of quality systems across all LSNE GMP locations.

JOB DUTIES

  • Leading Quality Assurance oversight of product release, batch record execution, batch record review, approval of production deviations, change controls, compliance, and investigations.

  • Working with project teams to represent the Quality organization, conducting risk assessments and introducing best practices into the Quality Management Systems across all LSNE business units.

  • Leading the commercial quality unit to include manufacturing record review, raw data review, investigation review and final release of drug product.

  • Leading QA personnel, including organizing and prioritizing group tasks, performing training, writing performance reviews and guiding personnel in longer-term development. Overseeing Quality Risk Management activities.

  • Providing QA oversight of QC Chemistry and Microbiology testing in support of site batch manufacturing.

  • Driving technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance.

  • Providing QA oversight/leadership during FDA and EMA site inspections.

  • Demonstrates substantial knowledge of industry best practices and trends.

  • Other tasks as assigned by management

EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE

  • 10+ years Pharmaceutical or Biotechnology industry experience. Prior experience in leading a commercial, aseptic drug product quality assurance team highly preferred

  • 5+ years previous QA management/leadership experience

  • BS in Chemistry, Biochemistry, Microbiology, Pharmaceutics, Biology or related life sciences field. Advanced level degree preferred

  • Quality leadership experience working on cross-functional teams to harmonize operational and compliance processes.

  • Quality Operations leadership within Quality Systems, Quality Compliance, Document Control, Quality Engineering, Validation or Technical Operations capacities.

  • Prior experience in a CMO or dealing with CMOs preferred

  • Medical Device experience a plus

  • Demonstrates excellent verbal, written, and interpersonal communication skills.

  • Demonstrated ability to perform in a fast paced environment

  • In depth knowledge of aseptic manufacturing practices and current industry trends for visual inspection of injectable products.

  • Prior experience hosting regulatory inspections, leading inspection readiness activities, and leading Pre-Approval Inspections (PAI) preferred.

PHYSICAL REQUIREMENTS

  • Must be able to walk or move about between locations

  • Must be able to sit or stand for prolonged periods of time.

COMMUNICATIONS & CONTACTS

  • Works closely with internal quality assurance teams.

  • Interacts with all departmental staff and other departments at all levels.

  • Must be comfortable presenting technical and complex issues clearly to all levels of management as well as client representatives.

MANAGERIAL & SUPERVISORY RESPONSIBILITIES

  • Management of 5+ direct reports.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Executive Director Of Behavioral Health Services Line

Elliot Health System

Posted 2 weeks ago

VIEW JOBS 5/9/2020 12:00:00 AM 2020-08-07T00:00 POSITION SUMMARY The Executive Director, Behavioral Health Service Line Leads Solution Health#s efforts to include the development and implementation of system-level strategic plans, policies and procedures in the area of Behavioral Health and provides overall administrative direction and coordination for all areas of Behavioral Health. The E.D. collaborates with Health System leadership to accomplish Service Line Goals and Objectives and is accountable for providing operational leadership, financial, clinical, business development, care coordination, and standardization goals for the service line in collaboration with dyad medical leadership. The E.D. is responsible for emphasizing consistency of standards and ensuring clinical and administrative #best practices# are communicated, shared, and implemented throughout the system. # # PRIMARY DUTIES AND RESPONSIBILITIES 1.Responsible for program development in all areas of responsibility, including patient service delivery, financial success to budget, and new program development # 2.Responsible for planning, directing, and coordinating initiatives around growth, quality # patient safety, customer service, provider integration, community health initiatives and consistency of practice for the system#s Behavioral Health Service Line # 3.Utilizes the service line model to help support the structure for population health management # 4.Partners with Community Health leadership to develop an effective behavioral health outreach strategy # 5.Fosters provider relationships and ensures all provider activities including patient schedules, clinic operations, patient volumes, and other activities are maximized # 6.Works collaboratively with health system leadership, operational leaders and external parties to accomplish objectives, facilitate cross-functional teams, and ensure that the service line meets all goals # 7.Supervises assigned direct reports within the organization # 8.Responsible for selecting and maintaining qualified personnel, identifying needs, recommending employee actions, and communicating the progress of plans # 9.Guides employees by interpreting policies and goals # 10.Participates in annual budgeting process and promotes financial performance within an acceptable budget variance. Applies strategic objectives into budgeting process. # 11.Ensures adequate operational measures are in place and monitored to maintain compliance with all organizational processes and policies. Complies with all HIPAA and compliance regulations # 12.Attends mandatories or in-services as needed, accepts further training as needed, remains updated as to policy/procedural changes # # ESSENTIAL JOB FUNCTIONS 1.Works under the direction of and collaboration with Senior Leadership to define strategic plans, organizational objectives and goals, implementation plans and measurement tools to monitor successful completion of objectives # 2.Assists in the development of and participates and/or leads division and organizational initiatives as requested # 3.Defines, analyzes, and reviews performance against operating plans; applies expertise to generate new ideas and concepts in operations and services, which will increase profitability and/or productivity; improves customer service and decreases expenses # 4.Prepares and implements business plans including goals for clinical quality, customer satisfaction, provider alignment, financial performance and operational results # 5.Identifies innovative trends and opportunities related to Behavioral Health service delivery and assesses viability for SolutionHealth # 6.Facilitates processes to align policies in all behavioral health environments, for the purpose of reducing variation and standardizing best practices # 7.Advances models of population health that include proactive engagement and alignment of behavioral health practices with the overall strategy # 8.Closely coordinates with process improvement partners to allow providers to practice at the top of their license # 9.Develops proformas/SBARs for new behavioral health programs # 10.Establishes standardized quality measures and tracks behavioral health program and provider performance # # POSITION QUALIFICATIONS # Education: Minimally Required: BA/BS degree required. Preferred: MBA/MHA/MPH or equivalent experience. # Experience: Minimally Required: 10 Years of health care leadership experience with significant exposure to matrix operating structures and experience with Behavioral Health inpatient and outpatient program development. Preferred: Direct experience leading a behavioral health service line within an integrated health care system. # Knowledge: Minimally Required: Group Facilitation Skills Lean Management Program Evaluation Budget Development # Skills: Minimally Required: Must have strong analytical skills and be creative to plan and accomplish a variety of goals. Excellent teambuilding, written and oral communication skills. Requires strong administrative, management and personnel recruitment skills. # Abilities: Minimally Required: Ability to successfully represent organization across The Health System and with external organizations. Ability to translate strategic objectives into actionable plans. Must be results-oriented. Practice servant leadership. Ability to maintain strong working relationships and be adaptable to change. Leads by example and holds self accountable for assigned responsibilities. POSITION SUMMARY The Executive Director, Behavioral Health Service Line Leads Solution Health's efforts to include the development and implementation of system-level strategic plans, policies and procedures in the area of Behavioral Health and provides overall administrative direction and coordination for all areas of Behavioral Health. The E.D. collaborates with Health System leadership to accomplish Service Line Goals and Objectives and is accountable for providing operational leadership, financial, clinical, business development, care coordination, and standardization goals for the service line in collaboration with dyad medical leadership. The E.D. is responsible for emphasizing consistency of standards and ensuring clinical and administrative "best practices" are communicated, shared, and implemented throughout the system. PRIMARY DUTIES AND RESPONSIBILITIES 1.Responsible for program development in all areas of responsibility, including patient service delivery, financial success to budget, and new program development 2.Responsible for planning, directing, and coordinating initiatives around growth, quality & patient safety, customer service, provider integration, community health initiatives and consistency of practice for the system's Behavioral Health Service Line 3.Utilizes the service line model to help support the structure for population health management 4.Partners with Community Health leadership to develop an effective behavioral health outreach strategy 5.Fosters provider relationships and ensures all provider activities including patient schedules, clinic operations, patient volumes, and other activities are maximized 6.Works collaboratively with health system leadership, operational leaders and external parties to accomplish objectives, facilitate cross-functional teams, and ensure that the service line meets all goals 7.Supervises assigned direct reports within the organization 8.Responsible for selecting and maintaining qualified personnel, identifying needs, recommending employee actions, and communicating the progress of plans 9.Guides employees by interpreting policies and goals 10.Participates in annual budgeting process and promotes financial performance within an acceptable budget variance. Applies strategic objectives into budgeting process. 11.Ensures adequate operational measures are in place and monitored to maintain compliance with all organizational processes and policies. Complies with all HIPAA and compliance regulations 12.Attends mandatories or in-services as needed, accepts further training as needed, remains updated as to policy/procedural changes ESSENTIAL JOB FUNCTIONS 1.Works under the direction of and collaboration with Senior Leadership to define strategic plans, organizational objectives and goals, implementation plans and measurement tools to monitor successful completion of objectives 2.Assists in the development of and participates and/or leads division and organizational initiatives as requested 3.Defines, analyzes, and reviews performance against operating plans; applies expertise to generate new ideas and concepts in operations and services, which will increase profitability and/or productivity; improves customer service and decreases expenses 4.Prepares and implements business plans including goals for clinical quality, customer satisfaction, provider alignment, financial performance and operational results 5.Identifies innovative trends and opportunities related to Behavioral Health service delivery and assesses viability for SolutionHealth 6.Facilitates processes to align policies in all behavioral health environments, for the purpose of reducing variation and standardizing best practices 7.Advances models of population health that include proactive engagement and alignment of behavioral health practices with the overall strategy 8.Closely coordinates with process improvement partners to allow providers to practice at the top of their license 9.Develops proformas/SBARs for new behavioral health programs 10.Establishes standardized quality measures and tracks behavioral health program and provider performance POSITION QUALIFICATIONS Education: Minimally Required: BA/BS degree required. Preferred: MBA/MHA/MPH or equivalent experience. Experience: Minimally Required: 10 Years of health care leadership experience with significant exposure to matrix operating structures and experience with Behavioral Health inpatient and outpatient program development. Preferred: Direct experience leading a behavioral health service line within an integrated health care system. Knowledge: Minimally Required: * Group Facilitation Skills * Lean Management * Program Evaluation * Budget Development Skills: Minimally Required: Must have strong analytical skills and be creative to plan and accomplish a variety of goals. Excellent teambuilding, written and oral communication skills. Requires strong administrative, management and personnel recruitment skills. Abilities: Minimally Required: * Ability to successfully represent organization across The Health System and with external organizations. * Ability to translate strategic objectives into actionable plans. * Must be results-oriented. * Practice servant leadership. * Ability to maintain strong working relationships and be adaptable to change. * Leads by example and holds self accountable for assigned responsibilities. Elliot Health System Bedford NH

Associate Director, Quality Assurance

Lsne Contract Manufacturing