Labeling Change Management and Quality Lead (m/f)
The purpose of this role is to lead the Artwork & Labelling Global Quality team for Shire. This team is responsible for oversight of the artwork management/labelling change process to ensure clear requirements are defined and executed to enable release of artwork to CMO/print vendor.
This role leads and/or supports global project teams, ensures effective deployment of internal/external quality and regulatory requirements, and drives harmonization and continuous improvement efforts globally in alignment with Shire’s Quality Management System, specifically in the area(s) of responsibility and Subject Matter Expertise (SME).
75%: Oversight of the artwork management/labeling change process to ensure clear requirements are defined and executed to enable release of artwork to CMO/print vendor.
- Leads the Artwork and Labeling Global Quality team for Shire
- Presides as the Subject Matter Expert (SME) for Quality Systems in the area(s) of responsibility/expertise
- Responsible for fostering an environment that embraces employee development and holds teams responsible for managing performance, developing a strong talent bench, and succession plan for key roles
- Manages contractors, direct reports and/or other quality personnel as required
- Budget development, monitoring and adherence for Artwork & Labeling Quality Team
- Supports integration of new acquisitions in to the Shire Quality System in the area(s) of responsibility and expertise
- Acts as a mentor to others within the organization to further develop others and grow the organization
25%: Other duties as necessary/requested/time permits:
- Participate in auditing of artwork outsource(s) as requested
- Participates and/or interfaces with inspectors during regulatory inspections
- Develops, gathers, and evaluates relevant metrics
- Develops, owns and performs training for global procedures related to his/her area(s) of expertise
- Obtain resolution on areas identified as non-conformance related to his/her area(s) of expertise
- Drives innovation within areas of responsibility through identifying and implementing continuous improvement opportunities with the objective of achieving operational excellence
Education and Experience Requirements
- Bachelor’s degree or equivalent in engineering or applied science
- Advanced degree in complimentary field of study
- >10 years in pharmaceutical manufacturing/quality operations
- Packaging and labeling experience
- Experience leading teams in multiple regions
- Auditing experience
- People manager and leader capable of developing people and teams with > 5 years of management experience (preferred)
- Oversight of CMO Operations (preferred)
Key Skills, Abilities, and Competencies
- Recognized as a leader and key collaborator with the ability to work in a matrix environment
- Knowledge of FDA regulations and GxPs
- Ability to make difficult, but robust, rationalized and timely decisions balancing the totality of available data and risk
- Must be self-driven and have the ability to operate with limited direction and be able to give direction to contractors, direct reports, and/or other personnel
- Ability to create a vision and motivate others to achieve that vision
- Ability to create an enabling culture and corresponding high performing team
- Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information with a team, and to champion change
- Must be detailed oriented, have the ability to meet deadlines, and have excellent leadership, and communication skills
- Demonstrate strategic thinking, business acumen and process assessment capability
- Organizational agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence and trust of stakeholders
- Must have the ability to handle highly complex problems and have excellent analytical and investigational skills
- Strong process and project management skills
- Adopt and exemplify the Shire leadership behaviors: Be positive, Be accountable, Be results driven and Be an excellent manager of self and others
Other Job Requirements
Domestic and international travel will be required to facilitate robust partnerships and execution. Depending on growth of organization and the primary work location, travel is estimated to be 20%.
Company Insights https://youtu.be/ly_8oO-iJeU
Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 4,500,- gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field!
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