- Responsible for the strategic planning of Packaging Operations.
- Oversees the tactical and operational performance (safety, quality compliance, delivery, cost & people)) of the Packaging function.
- Coordinates the activities of department management and provides direction and assistance in the resolution of complex issues, and/or issues pertaining to safety, quality compliance or supply which may arise.
- Responsible for budgeting, cost control, and the financial performance of Packaging Operations.
- Responsible for the performance of contract personnel and providers engaged to support Operations.
- Responsible for delivering the people strategy for Packaging Operations aimed at developing staff for career progression to ensure agility, flexibility and readiness for the future. Ensure that Individual Development Plans (IDPs) link to future business needs are in place for all colleagues.
- Works with senior and executive management to develop and deploy strategies for operations.
- Conducts and serves as a lead/coordinator of investigations and corrective and preventative action (CAPA) recommendations related to Packaging Operations.
- Interfaces with regulatory agencies as required representing Gilead to authorities and regulatory inspectors in matters relating to Operations.
- Establishes and manages key performance indicators (KPIs) to measure functional performance and effectiveness.
- Responsible for leading/sponsoring key NPI, operational and or capital projects as agreed through the site strategy deployment processes.
- Responsible for oversight and direction of all departmental projects.
- Acts as an escalation point for complex/high impact manufacturing issues/decisions.
- Area of expertise should include operational management, group management, operational excellence, capital planning, project management, long range strategic planning, cGMP compliance, regulatory compliance.
- Demonstrated track record in advanced leadership and strategic management.
- Competent on budget management, resource & capacity planning for a large function.
- Competent in master production scheduling through to the finite scheduling cycle and execution tracking.
- Demonstrated ability to independently exercise judgment and lead and motivate teams to determine and deliver appropriate solutions.
- Demonstrated ability to develop solutions to complex problems requiring a high degree of ingenuity, creativity and innovation.
- Proven ability to lead cross-functional teams in a matrixed fast-paced work environment.
- Proven track record in engaging, developing and retaining talent.
- Excellent analytical/ problem solving skills.
- Excellent verbal, written, and interpersonal communication skills, with experience writing technical reports.
- Advanced Project management, change management and stakeholder management skills
- Motivated individual, who can work independently, with effective planning and prioritization skills.
- Demonstrates strong, organizational, and project management skills required.
- Relevant experience and BS or related fields.
- Masters degree, PhD or an advanced business degree such as an MBA is desirable.
- Formal OE qualification (GB, BB, KT, Lean etc.) desirable.
- Extensive Operations Management experience within Pharmaceutical / Biopharmaceutical manufacturing, and/or packaging and distribution is desirable.
- Extensive knowledge of industry best practices and trends
- Demonstrated strong knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements for Biopharmaceutical or Pharmaceutical manufacturing and distribution.
- Resilient profile with the ability to deliver in an ambiguous environment
- Ability to engage and manage multiple stakeholders to achieve the objective
- Objective, can-do attitude, and a growth mindset
- Curious with learning agility
- Operational excellence mindset
- Organized with systematic approach to prioritization
- Process orientated to achieve the business objective
- Equally focused on the "What" that is to be deliver and the "How" it will be delivered
Director of Packaging - Cork, Ireland - Gilead Sciences Ireland UC
Description
Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff of more than 7,000 people is a close community where you can see the tangible results of your contributions, where every individual matters and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in more than 20 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By working at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
The Commercial Pharmaceutical Manufacturing organization is responsible for commercial drug product manufacturing, including knowledge transfer to Contract Manufacturing Organizations to meet Gilead's technical, regulatory and compliance standards, in order to ensure a sustainable delivery of quality product to the patients.
Director Packaging Operations
The Director of Packaging Operations will be responsible for developing and directing the overall strategy of the Packaging function, sponsoring key capital projects/NPIs and will be responsible for strategy deployment. The position will be responsible for the overall performance of Packaging Operations.
Specific responsibilities for the position:
Knowledge and Skills:
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
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