Reporting to the Senior Manager Product Quality, the post holder will be responsible for supervising a team of Product Quality (PQ) Specialists in their oversight of global suppliers of pharmaceutical products and will undertake operational PQ activities. The supervisor will co-ordinate and support the activities of their team and provide support to the wider PQ group. They will ensure that licensed pharmaceutical products for the US based NorthStar/Aisling private labels (PL) are manufactured and tested in compliance with CGMPs specific to United States FDA. The supervisor will also ensure, support is provided to Sivem, a sister private label in Canada, for NorthStar sourced products in compliance with Health Canada regulations. The post holder will be required to offer technical guidance to the team and vendors in accordance with business needs. The post holder should be familiar with US, Canadian and international regulations.
Supervise a team of PQ specialists to provide appropriate quality oversight of products and reduce risk to McKesson PLs
Provide direction and support to team and suppliers
Liaise and build relationships with manufacturers and stakeholders
Ensure product complaints are investigated and closed and escalation of serious complaints to quality management and suppliers
Ensure timely evaluation of PQ documentation for all batches to ensure compliance to GMP prior to shipping and distribution as per NH procedures.
Ensure the timely investigation of temperature excursions during shipment
Ensure timely assessment of deviations, change controls, laboratory Investigations and CAPA's and follow up with suppliers to ensure effective understanding of quality issues and resolution prior to batch acceptance
Liaise with suppliers on product risks such as Field alerts and potential market actions
Be vigilant for situations which may require quarantine and events which may impact DSCSA compliance
Provide batch screening and new product launch support to Sivem PL for NorthStar sourced products product quality support
Provide support for NPL across the US Private Labels
Promote collaboration, make timely disciplined decisions, and drive results in accordance with iCARE and iLEAD principles
Support quality and business improvement projects as required
Establish individual goals and objectives and delegate assignments to direct reports
Empower, coach, support personnel development needs, and professional goals to inspire the team to succeed
Keep Quality Management and team updated on issues which impact the business
Promote a culture of continuous improvement throughout the team and organisation
Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills and knowledge as required and as required
ADDITIONAL RESPONSIBILITIES AND DUTIES:
The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties. Additional responsibilities may be assigned, as required, by management.
Educated to degree level or higher, ideally B.Sc. or post graduate studies in Chemistry, Microbiology, Chemical Engineering; other related scientific disciplines may be considered.
Experience: 5+ years experience, in finished dose pharmaceutical manufacturing and/or medical devices; preferably in a progressive multinational organization. The post holder will have technical manufacturing, quality, or laboratory experience. Previous supervisory or managerial experience is not a prerequisite but is desirable.
Knowledge and Skills:
Solid understanding and knowledge of CGMP and the regulatory framework for the manufacture and supply of finished dose pharmaceutical products
Proven record in analytical decision making
Ability to communicate at all levels within the organization and influence others to drive results
Ability to work independently and make decisions based on judgement and integrity
Ability to transfer findings into report and presentation formats
Ability to work effectively with others inside and outside their team to accomplish goals in a timely manner
Excellent technical writing, organizational and time management skills
An understanding of relevant directives, standards, policies and guidelines and the ability to implement appropriately
Desire to supervise and develop others to improve performance or effectiveness
Exhibits leadership capabilities
MS Office; knowledge of Quality Software or statistical packages is desirable.
Work Environment/Physical Demands:
Hybrid working model with ability to work at home and in general office environment. Foreign travel may be required from occasionally to meet business needs.
We deliver careers with purpose and potential. Our focus on better health starts with creating an inclusive environment with strong values where you can build a fulfilling career. You can count on us to provide you with resources and opportunities to grow and be your best, while contributing to our pursuit of improving lives. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient. We work to distribute medical supplies, bandages, syringes, vials of flu vaccine, and pharmaceutical drugs to help real patients like Jack, an eight-year-old boy battling cancer. We take that job seriously. Together, the work we do is shaping the future of healthcare. If you are passionate about combining a meaningful career with a balanced life, join us on this journey and apply for a job with McKesson today. Every day, McKesson’s employees deliver products to healthcare providers that make a difference in the care and life of a patient.