Are you a QA Manager with experience in the Biotechnology / Pharmaceutical industry? Would you like to work for a multinational company with a plant in Cork? This a permanent, full time role, with excellent salary and benefits.
QA Manager - Biotech - Cork
Job Description
This includes document management, as well as all activities related to material release. In addition, the person will be responsible for the management of several quality systems including investigations, corrective actions and change control. They will set quality standards in respect of manufacturing and engineering systems and monitor compliance with those standards
Responsibilities Include:
Responsible for appropriately staffing and developing the Quality Assurance organization to meet business needs and succession plans.
Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the company Standard of Leadership behavior model.
Partners with other company Quality personnel to ensure harmonization and alignment with company Quality Policies, Guidelines, Programs and Systems.
Active member of the Operational Leadership Team.
Supports Quality PE and Metrics Program.
Provide leadership to direct reports and the site through:
Develops and champions an organizational culture that promotes behaviors that lead to superior business performance and organisational excellence.
Creates a commitment to customer service.
Encourages, supports and directs initiatives and programmes that lead to improved quality and improved regulatory compliance.
Manages and guides staff and those involved in quality activities to achieve the best results
Mentors and coaches staff, as well as develops and implements training programmes, to ensure professional and personal development of department personnel.
Interfaces professionally with other company departments, as well as staff from other affiliates in fulfilling his/her responsibilities.
Ensures all employees comply with all applicable company and governmental (EPA,OSHA, FDA, etc.) regulations, policies and guidelines.
Gives operational direction to the QA group in the execution of their duties.
Coordinates the activities of the groups within quality to create a synergistic approach to goals and tasks.
Provides coaching, mentoring, and direction to Quality Assurance staff as appropriate.
Through personal expertise, leadership and commitment, provides direction to the site in the development of a culture of quality and compliance.
Requirements:
Excellent interpersonal skills
Quality management skills: problem solving, statistical thinking, design of experiments, etc
Relationship skills: negotiation skills, presentation skills, able to read the corporate culture, listening skills, harvests people’s energy, manages a diverse team.
Innovative, tenacious, and passionate about quality
Time management skills
Attention to detail without losing site of the big picture
Keeps up to date with technical and managerial developments in the industry
Results and performance driven
Adaptable and flexible
Essential:
Advanced degree required in a scientific or engineering discipline
5-10 years experience in a significant leadership position within the biological and/or pharmaceutical industry.
Experience in a Quality leadership role required
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals.
Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
Proven success in managing in a global organization
5 years experience in a supporting functional area (e.g. R&D, Manufacturing,Engineering, EHS, Technical Services)
Eligible for inclusion on the site manufacturing licence as Qualified Person
Package:
Permanent Full time position
€65-75K basic
Benefits - Pension, healthcare etc
Defined Benefit Pension Scheme, 10% from employer
Laya Healthcare for family
Performance related bonus - cash/shares
Share Options
Performance related bonus schemes
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Jobs in Cork
Are you a QA Manager with experience in the Biotechnology / Pharmaceutical industry? Would you like to work for a multinational company with a plant in Cork? This a permanent, full time role, with excellent salary and benefits.
QA Manager - Biotech - Cork
Job Description
This includes document management, as well as all activities related to material release. In addition, the person will be responsible for the management of several quality systems including investigations, corrective actions and change control. They will set quality standards in respect of manufacturing and engineering systems and monitor compliance with those standards
Responsibilities Include:
Responsible for appropriately staffing and developing the Quality Assurance organization to meet business needs and succession plans.
Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the company Standard of Leadership behavior model.
Partners with other company Quality personnel to ensure harmonization and alignment with company Quality Policies, Guidelines, Programs and Systems.
Active member of the Operational Leadership Team.
Supports Quality PE and Metrics Program.
Provide leadership to direct reports and the site through:
Develops and champions an organizational culture that promotes behaviors that lead to superior business performance and organisational excellence.
Creates a commitment to customer service.
Encourages, supports and directs initiatives and programmes that lead to improved quality and improved regulatory compliance.
Manages and guides staff and those involved in quality activities to achieve the best results
Mentors and coaches staff, as well as develops and implements training programmes, to ensure professional and personal development of department personnel.
Interfaces professionally with other company departments, as well as staff from other affiliates in fulfilling his/her responsibilities.
Ensures all employees comply with all applicable company and governmental (EPA,OSHA, FDA, etc.) regulations, policies and guidelines.
Gives operational direction to the QA group in the execution of their duties.
Coordinates the activities of the groups within quality to create a synergistic approach to goals and tasks.
Provides coaching, mentoring, and direction to Quality Assurance staff as appropriate.
Through personal expertise, leadership and commitment, provides direction to the site in the development of a culture of quality and compliance.
Requirements:
Excellent interpersonal skills
Quality management skills: problem solving, statistical thinking, design of experiments, etc
Relationship skills: negotiation skills, presentation skills, able to read the corporate culture, listening skills, harvests people’s energy, manages a diverse team.
Innovative, tenacious, and passionate about quality
Time management skills
Attention to detail without losing site of the big picture
Keeps up to date with technical and managerial developments in the industry
Results and performance driven
Adaptable and flexible
Essential:
Advanced degree required in a scientific or engineering discipline
5-10 years experience in a significant leadership position within the biological and/or pharmaceutical industry.
Experience in a Quality leadership role required
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals.
Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
Proven success in managing in a global organization
5 years experience in a supporting functional area (e.g. R&D, Manufacturing,Engineering, EHS, Technical Services)
Eligible for inclusion on the site manufacturing licence as Qualified Person
Package:
Permanent Full time position
€65-75K basic
Benefits - Pension, healthcare etc
Defined Benefit Pension Scheme, 10% from employer
Laya Healthcare for family
Performance related bonus - cash/shares
Share Options
Performance related bonus schemes
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Biotech / Pharma / Medical Device Jobs in Ireland
Jobs in Cork
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
