Operations Associate Director Job Description
Operations Associate Director Duties & Responsibilities
To write an effective operations associate director job description, begin by listing detailed duties, responsibilities and expectations. We have included operations associate director job description templates that you can modify and use.
Sample responsibilities for this position include:
Operations Associate Director Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Operations Associate Director
List any licenses or certifications required by the position: PMP, ITIL, APICS, UK, CPSM, JNCIA, CCNA, PMI, CCIE, CCDP
Education for Operations Associate Director
Typically a job would require a certain level of education.
Employers hiring for the operations associate director job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Education, Management, Business, Communication, Project Management, Engineering, Technology, Science, Business/Administration, MBA
Skills for Operations Associate Director
Desired skills for operations associate director include:
Desired experience for operations associate director includes:
Operations Associate Director Examples
Operations Associate Director Job Description
- Lead the goal setting process, linking team goals into strategic objectives
- Ensure that the daily/monthly performance is known by all, and that a continual process of improvement is in place and all successes celebrated and shared
- Maintain close supervision of staff attrition and absence levels, anticipate and identify causes
- Ensure that the staff are appropriately trained, deployed, appraised and motivated so that their individual and collective performance meets the needs of the business
- Manage the implementation and continual improvement of the Rewards & Recognition programme for the whole of Institutional Operations
- Ensure that the statutory, regulatory and compliance framework is in place and is adhered to
- Build a robust recruitment process to ensure the correct calibre of staff members are employed
- Leads manufacturing operations at the site
- Provides leadership and direction to dotted line local management support of co-located R&D
- Responsible for the production of all domestic employee annual statutory forms (Form W-2s, 1095-Cs ) and other year end reporting as required by law
- Proficiency with analyzing stochastic processes
- Knowledge of NoSQL platforms (e.g., MongoDB, Couchbase, MarkLogic )
- Demonstrates a clear understanding of policies & procedures of operations
- Five years plus of commercial sales related experience
- Responsible for establishing career development, training and succession planning
- Champions larger systems and process streamlining and consolidation
Operations Associate Director Job Description
- Monitor overall performance of services in real time
- Global focus on incidents and requests with the ability to work across regions and in collaboration with other SDMs ( Service Delivery Managers) in other regions
- Manage the local but globally aligned IT support group, supporting users in several countries—providing support via phone and email
- Manage IT Purchasing for EMEA
- Investigates site problems to provide solutions to complex and recurring problems
- Supports technical transfer of manufacturing processes to other facilities including support to external clients/projects
- Assists in transfer of new technology from Process Development to Manufacturing
- Supports technical transfer of test methods within Gilead to other locations/operations and provides on-site CMC support
- Assesses feasibility of new improved processes and conducts critical review of data/trends
- Evaluates use of alternate Raw Materials and supports QC on technical problems
- Comprehensive knowledge of all pertinent regulations
- Strong knowledge of IT systems and document management concepts
- Knowledge of FDA requirements for regulatory submissions
- 5 years in Regulatory Affairs with demonstrated ability to interact successfully with team members and health authorities where appropriate
- The qualified candidate will manage a team of process engineers for cell culture and purification operations to support the Gilead Biologics internal and external manufacturing activities
- Candidate will be responsible for the manufacturing process facility-fit assessments and process transfer activities to Gilead Manufacturing and Contract Manufacturing Organization (CMO) facilities in support of early- and late- stage production of the Gilead Biologics programs
Operations Associate Director Job Description
- Ensures technical services areas and equipment meet all current GMP and all other regulatory specifications
- Responsible for continuous improvement in all operation processes
- Work with key stakeholders to lead the development of new and existing sample programs building a framework for strategic direction and oversight of all direct-to-physician mail programs, ensuring compliance and operational effectiveness
- Identify solutions that support and enhance the capability to track operational efficiencies and effectiveness of programs
- Proactively manage the performance of critical vendors and internal processes to ensure the quality of deliverables, adherence to both internal and external standards and to streamline day-to-day operations and increase efficiency
- Develop PDMA compliance training programs and materials as it relates to sample operations
- Develop and maintain stringent quality control process and measures that ensures the accuracy of all report information and data extracts
- Lead alignment efforts with internal departments to develop, implement, and maintain effective processes and documentation
- Conduct routine internal reviews and audits of vendor activities to assure ongoing satisfactory
- Prepare and recommends program operating budgets for approval
- Responsible for the engineering modifications and retrofit activities at internal and external manufacture sites, remediation of facility-fit issues in support of external manufacture
- Strong understanding of cGMP commercial manufacturing and associated regulatory requirements, including proven experience supporting process and facility/equipment sections of BLA and MAA filings
- Support late-stage process validation activities for internal and external manufacturing facilities in support of Gilead Biologics programs
- Responsible for the design phase and/or engineering evaluation and improvement of clinical and commercial manufacturing facilities as needed
- Support internal and external quality audits and regulatory inspections
- Extensive experience in facility fit evaluation/remediation and successful technology transfers into internal and contract manufacturing sites
Operations Associate Director Job Description
- Oversee the development and implementation of standardized sample program work instructions and procedures to ensure compliance with corporate procedures
- Work with staff to develop objective performance measurements across all sites, to ensure consistent, high-quality evaluation and goal setting for all employees
- Manage and oversee the day to day operations of Sarilumab and Dupilumab reimbursement support, clinical services, bridge product and patient assistance programs to budget and performance metrics
- Drive initiatives to ensure the Patient Support Programs provides best in class support to minimize reimbursement as a barrier in the physician office setting and enhance overall patient access to therapy
- Understand and analyze program data to effectively communicate information on a consistent basis to different functional areas in the commercial organization (sr
- Manage MBA and Alumni Coaching program operations including oversight of 38 contract or LHT coaches and managing communications to all coaches (including 14 HU employees)
- Recruit, assist in hiring and onboarding of new coaches needed to balance the coaching portfolio based on changing MBA and Alumni career interests and needs
- Recruit and coordinate coaches to staff all coach-led programs including Alumni reunion coaching, Resumania, practice interviews, and all resume and cover letter reviews
- Train and supervise two Coaching Coordinators who manage program logistics and data analysis
- Evaluate coaching effectiveness and oversee all program analytics (appointment volume, ratings and participation at trainings) that affect coach compensation and indicate program usage
- Responsible for authoring and/or reviewing relevant IND/BLA sections and generating responses to global regulatory agencies
- Routine interactions with internal and external operations, engineering, quality and technical groups
- Routine progress reports and updates addressing ongoing technology transfers and manufacturing campaigns
- Excellent communication and collaboration with support groups, including QA, QC, Manufacturing Operations, Regulatory Affairs, Supply Chain, Engineering, Facilities, Biologics Outsourcing and Biologics Process Development
- Work closely with CMC Project Teams and Regulatory Affairs to aid in the delivery of high quality regulatory submissions
- Manage interactions with contract manufactures (CMOs)
Operations Associate Director Job Description
- With Director and Senior Advisor, oversee logistics and related training content at annual and monthly coach peer review meetings with Director and Senior Advisor
- Other CPD office-wide responsibilities as needed
- The Associate Director GMP Operations is responsible for the operations and day to day activities for the GMP Pilot Plant area
- Review technical requirements to ensure alignment with business requirements and projects, providing constructive input and direction for blueprint consumed by operational teams
- Act as SME for Critical Response Team (CRT), providing diagnostics and corrective actions and engaging 3rd party vendors as necessary
- Provide timely incident reporting to IT governance and ensure post mortems for complex incidents are conducted
- Test and certify all new OS software releases
- Develop and implement the patient affordability and reimbursement programs specifics including patient free product assistance, commercial co-pay, quick start, and foundation donations
- Manage the implementation of patient affordability and reimbursement programs ensuring service provider meets timelines and provides quality deliverables
- Assist in the development and maintenance of program documents, such as policies and procedures, exception processes, and working instructions related to areas of responsibility
- Is comfortable interacting with regulatory agencies as needed and possesses the ability to represent Gilead in public forums
- Demonstrates broad experience across areas such as manufacturing and understanding of parenterals, aseptic and BDS operations
- 10+ years of experience in the pharmaceutical industry and a BS or BA
- 8+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA
- Advanced degree preferred, MS and/or PhD
- 3 + years in a process engineering role preferred