Sr. Manager Quality - International
SUMMARY OF POSITION:
This individual will provide management of critical compliance and quality projects that affect the different global regions, mainly US and LATAM regions deserved by Mallinckrodt. For example, this individual may lead large or complex projects affecting multiple regions, represent quality on project teams and champion key quality initiatives and long-term strategic plans.
This individual is responsible to oversee the processes associated with maintaining the site’s Quality System, including: developing, establishing and continuously improving site CAPA system, quality assurance programs, quality policies, investigation and trending of quality data streams as it is related to quality international activities. The Sr. Manager, International Quality is responsible to drive compliance based programs to ensure the Quality Department supports internal and external customer requirements. This position reports directly to the Sr. Director, Quality. Internal customer groups will rely heavily on the incumbent to make data driven and highly technical decisions in a timely manner and provide the support necessary to carry out those decisions.
- Ensure all cGMP/cGDP requirements are fulfilled for the supply of products (active substances for medicinal products for human use and, medicinal products) in accordance with country requirements
- Manage the process that develops, establishes, and maintains quality assurance programs, policies, process, procedures and controls ensuring that performance and quality of finished products (active substances for medicinal products for human use and medicinal products) in accordance with Good Distribution Practices requirements
- Identify, develop and execute quality plans and project timelines to meet group, site and company goals
- Oversee quality activities related to the distributors and distribution center (receipt, storage, re-labeling (where applicable), distribution, returns,)
- Manage the quality activities related to quality agreements and other customer requests
- Lead strategic quality efforts for projects identified by the business unit/region
- Participate in compliance audits and respond to audit observations
- Serves as auditor for supplier quality audits and internal audits
- Act as site Quality subject matter expert for regulatory agencies and corporate interfaces
- Lead/Host regulatory inspection and respond to inspection observations
- Will interact with corporate support groups to drive quality programs.
- Serve as cGMP/cGDP compliance subject matter expert
- Complete technical and other quality duties as assigned
Education required/ preferred:
- Minimum of 8years pharmaceutical and/or related medical devicesexperience
- Previous management level experience
- Thorough knowledge of cGMPs/cGDPs for APIs and medicinal products requirements
- Must be proficient at technical and compliance understanding of quality processes associated with quality, CAPA, deviations/exceptions, root cause analysis, change control and quality concepts in a distribution center/commercial office environment.
- Independent, self-starter who needs little guidance or follow-up once projects/tasks are assigned.
- Proficient at multi-tasking, well organized and reliable for consistent decision making and follow through.
- Demonstrated auditing and corrective action proficiency
- Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues
- Demonstrated proficiency of root cause analysis as applied in a pharmaceutical manufacturing environment. Excellent problem solving and decision making skills.
- Ability to manage and drive change
- Supervisory skills
- Computer skills
- Knowledge of document management/quality systems
- Direct experience with Regulatory inspection highly preferred
- Spanish writing/speaking
- Interpretive skills and discernment in the application of global quality models and regulations to a wide variety of specific quality attainment settings.
- Ability to matrix manage projects with multiple functional groups without direct reporting authority
- Strong communication and interpersonal skills
- Getting work done through others that are not direct reports
- Operates with minimal direction, self-starter
- Building relationships with other departments
- Interviewing and presentation skills
- Statistical Analysis capability
Normal office conditions
Travelrequired (10 - 30%) – both domestic and international
Frequent communication and working relationships with manufacturing sites, distribution centers, different functions within and outside the company (quality, operations, supply chain, distribution)
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.